Product Code: JHI FDA class 2 21 CFR 862.1155

Visual, Pregnancy Hcg, Prescription Use

Clinical Chemistry

Visual Pregnancy HCG (Prescription Use) is a clinical chemistry test system that uses a visual, typically immunochromatographic method to detect human chorionic gonadotropin (HCG) in urine or serum, confirming pregnancy in a prescription-use clinical setting. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JHI, regulated under 21 CFR 862.1155, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

375

FEI Numbers

110

Registration Numbers

110

Unique Applicants

156

Years Active

Basic Information

Product Code: JHI
Device Class: FDA class 2
Regulation Number: 862.1155
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 375 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241919	Innovita HCG Pregnancy Rapid Combo Test	Aug 02, 2024	Substantially Equivalent	Innovita (Tangshan) Biological Technology CO., LTD
K203272	Alltest Pregnancy Rapid Combo Test Cassette	Jan 31, 2022	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd
K172322	Atellica IM Total hCG (ThCG)	Mar 29, 2018	Substantially Equivalent	Siemens Healthcare Diagnostics Inc.
K172257	TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)	Dec 22, 2017	Substantially Equivalent	True Diagnostics, Inc
K152768	Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip	Feb 24, 2016	Substantially Equivalent	ASSURE TECH. CO., LTD.
K130456	WUNDER PREGNANCY TEST	Apr 08, 2014	Substantially Equivalent	JAMES NGUYEN
K132834	FASTEP S10 HCG SERUM/URINE COMBO TEST	Jan 09, 2014	Substantially Equivalent	POLYMED THERAPEUTICS, INC
K131166	SOFIA(R) HCG FIA	Aug 02, 2013	Substantially Equivalent	QUIDEL CORP.
K123844	CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST	May 30, 2013	Substantially Equivalent	CHEMTRON BIOTECH, INC.
K112101	FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS	Jul 17, 2012	Substantially Equivalent	POLYMED THERAPEUTICS, INC
K112315	HOME PREGNANCY TEST	Apr 23, 2012	Substantially Equivalent	NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
K102175	RAPIDVUE HCG TEST	Aug 25, 2010	Substantially Equivalent	QUIDEL CORPORATION
K072264	FASTPACK HCG IMMUNOASSAY	Dec 06, 2007	Substantially Equivalent	Qualigen, Inc.
K071030	BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC	Jun 29, 2007	Substantially Equivalent	APPLIED DNA TECHNOLOGIES, INC.
K070921	BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG	Jun 29, 2007	Substantially Equivalent	APPLIED DNA TECHNOLOGIES, INC.
K061257	DBEST HCG PANEL TEST KIT	May 04, 2007	Substantially Equivalent	AMERITEK USA, INC.
K062361	INNOVACON HCG UKTRA TEST DEVICE	Oct 23, 2006	Substantially Equivalent	INNOVACON, INC.
K050955	LIFESIGN DXPRESS, MODEL LSR2000	Jan 23, 2006	Substantially Equivalent	PRINCETON BIOMEDITECH CORP.
K052694	ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.	Dec 16, 2005	Substantially Equivalent	IND DIAGNOSTIC INC.
K051841	WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST	Aug 22, 2005	Substantially Equivalent	W.H.P.M., INC.
K050741	IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT	May 16, 2005	Substantially Equivalent	IND DIAGNOSTIC INC.
K043385	OSOM HCG COMBO TEST	Apr 12, 2005	Substantially Equivalent	GENZYME DIAGNOSTICS
K041946	ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE	Aug 16, 2004	Substantially Equivalent	ACON LABORATORIES, INC.
K041728	HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE	Aug 11, 2004	Substantially Equivalent	IMMUNOSTICS, INC.
K033297	ZAP HCG TEST, MODEL 8001	Mar 18, 2004	Substantially Equivalent	ZBX CORPORATION
K032563	CLINITEST HCG PREGNANCY TEST	Dec 23, 2003	Substantially Equivalent	BAYER HEALTHCARE, LLC
K032987	ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005	Nov 17, 2003	Substantially Equivalent	UNOTECH DIAGNOSTICS, INC.
K031445	MAINLINE MAXIE HCG URINE PREGNANCY TEST	Jul 01, 2003	Substantially Equivalent	MAINLINE TECHNOLOGY, INC.
K031048	CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST	Jun 16, 2003	Substantially Equivalent	ACCESS BIO INCORPORATE
K023823	EASYCUP	May 22, 2003	Substantially Equivalent	ZER HITECH
K030430	POLY STAT SERUM/URINE HCG TEST	Apr 18, 2003	Substantially Equivalent	ALIDEX, INC.
K023944	BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST	Feb 11, 2003	Substantially Equivalent	BAYER CORP.
K023544	GENZYME CONTRAST II HCG URINE/SERUM TEST	Jan 16, 2003	Substantially Equivalent	GENZYME CORP.
K023480	ACCESS TOTAL BHCG	Dec 20, 2002	Substantially Equivalent	BECKMAN COULTER, INC.
K022683	SAS BLOOD/SERUM/URINE/URINE HCG	Dec 16, 2002	Substantially Equivalent	SA SCIENTIFIC, INC.
K021386	POLY STAT HCG DIPSTICK TEST	Aug 05, 2002	Substantially Equivalent	ALIDEX, INC.
K020968	LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD	Jul 15, 2002	Substantially Equivalent	PAN PROBE BIOTECH, INC.
K020378	QUPID PLUS E.R.	Jun 21, 2002	Substantially Equivalent	STANBIO LABORATORY
K020439	STATUS HCG SERUM/URINE	May 23, 2002	Substantially Equivalent	PRINCETON BIOMEDITECH CORP.
K020801	QUICKVUE ONE-STEP HCG-COMBO	May 17, 2002	Substantially Equivalent	QUIDEL CORP.
K020799	QUICKVUE ONE-STEP HCG-URINE	May 17, 2002	Substantially Equivalent	QUIDEL CORP.
K020438	SAS VALUE HCG	Mar 08, 2002	Substantially Equivalent	SA SCIENTIFIC, INC.
K020128	ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500	Mar 01, 2002	Substantially Equivalent	DIAGNOSTIC SYSTEMS LABORATORIES, INC.
K013702	VICTORCH HCG TEST STRIP	Dec 27, 2001	Substantially Equivalent	VICTORCH MEDITEK, INC.
K012559	POLY STAT HCG TEST	Oct 16, 2001	Substantially Equivalent	BION DIAGNOSTIC SCIENCES
K013194	UNIMARK HCG COMBO PREGNANCY TEST	Oct 10, 2001	Substantially Equivalent	BIOTECH ATLANTIC, INC.
K012284	WH ACCU TEST PREGNANCY TEST	Aug 28, 2001	Substantially Equivalent	W.H.P.M., INC.
K011550	HCG STAT PAK ULTRA-FAST	Aug 14, 2001	Substantially Equivalent	Chembio Diagnostic Systems, Inc.
K010522	SUREVUE URINE HCG	Jul 31, 2001	Substantially Equivalent	SA SCIENTIFIC, INC.
K010593	SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT	Apr 05, 2001	Substantially Equivalent	SA SCIENTIFIC, INC.
K003856	EZ-HCG URINE(PREGNANCY TEST)	Feb 21, 2001	Substantially Equivalent	BIOMERICA, INC.
K001215	DBEST HCG 2 IU/ML TEST KIT	Jun 22, 2000	Substantially Equivalent	AMERITEK, INC.
K994227	ADVANTAGE HCG TEST (URINE/SERUM)	Feb 03, 2000	Substantially Equivalent	ADVANTAGE DIAGNOSTICS CORP.
K993703	CLEARVIEW EASY HCG PREGNANCY TEST	Dec 02, 1999	Substantially Equivalent	UNIPATH LTD.
K993317	ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)	Dec 01, 1999	Substantially Equivalent	ACON LABORATORIES, INC.
K993203	ACON ONE STEP PREGNANCY TEST STRIP (URINE)	Dec 01, 1999	Substantially Equivalent	ACON LABORATORIES, INC.
K992915	ONE-STEP DOUBLE-CHEK PREGNANCY TEST	Nov 18, 1999	Substantially Equivalent	BIOMEDICAL PRODUCTS CORP.
K992695	INSURE PRO TEST	Oct 18, 1999	Substantially Equivalent	INBIOS INTL., INC.
K993065	ACON COMBO PREGNANCY	Oct 08, 1999	Substantially Equivalent	ACON LABORATORIES, INC.
K992397	ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE	Aug 26, 1999	Substantially Equivalent	CENOGENICS CORP.
K991741	BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027	Jul 22, 1999	Substantially Equivalent	BIOCHECK, INC.
K990741	SAS ONE-STEP PREGNANCY	May 10, 1999	Substantially Equivalent	SA SCIENTIFIC, INC.
K990684	MODIFICATION OF SAS SERUM/URINE HCG	May 10, 1999	Substantially Equivalent	SA SCIENTIFIC, INC.
K991095	QUICKCARD HCG COMBO TEST, MODEL #9014	Apr 28, 1999	Substantially Equivalent	PHAMATECH
K991067	MODIFICATION OF: DAVIDSTRIP HCG	Apr 27, 1999	Substantially Equivalent	SIMEX MEDICAL, INC.
K990578	OSOM CARD II HCG-URINE TEST, MODEL 102	Mar 09, 1999	Substantially Equivalent	WYNTEK DIAGNOSTICS, INC.
K984080	INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST	Feb 16, 1999	Substantially Equivalent	ALFA SCIENTIFIC DESIGNS, INC.
K984079	INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST	Feb 16, 1999	Substantially Equivalent	ALFA SCIENTIFIC DESIGNS, INC.
K984077	INSTANT-VIEW PREGNANCY COMBO TEST	Feb 16, 1999	Substantially Equivalent	ALFA SCIENTIFIC DESIGNS, INC.
K984076	INSTANT-VIEW PREGNANCY URINE TEST	Feb 16, 1999	Substantially Equivalent	ALFA SCIENTIFIC DESIGNS, INC.
K981444	BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP	Jul 22, 1998	Substantially Equivalent	PRINCETON BIOMEDITECH CORP.
K981838	ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002	Jun 25, 1998	Substantially Equivalent	UNOTECH DIAGNOSTICS, INC.
K981443	BIOSIGN HCG I - ONE STEP PREGNANCY TEST	Jun 25, 1998	Substantially Equivalent	PRINCETON BIOMEDITECH CORP.
K981770	RAPIDHCG PREGNANCY TEST	Jun 05, 1998	Substantially Equivalent	RAPID DIAGNOSTICS, INC.
K981512	ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025	May 28, 1998	Substantially Equivalent	SKD, INC. A BECKMAN COULTER CO.
K981165	AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST	Apr 16, 1998	Substantially Equivalent	GERMAINE LABORATORIES, INC.
K980736	ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST	Apr 16, 1998	Substantially Equivalent	ACON LABORATORIES CO.
K974060	MINISTRIP/ SERUM AND URINE COMBO HCG TEST	Apr 09, 1998	Substantially Equivalent	INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K980896	QUICKCARD PRO HCG TEST, MODEL 9008	Apr 02, 1998	Substantially Equivalent	PHAMATECH
K980173	ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505	Mar 18, 1998	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K974009	PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG	Mar 13, 1998	Substantially Equivalent	INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K980531	AIMSTEP PREGNANCY	Mar 06, 1998	Substantially Equivalent	GERMAINE LABORATORIES, INC.
K980205	SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST	Feb 12, 1998	Substantially Equivalent	SAN DIEGO BIOTECH
K974615	QUICKSTICK PRO HCG TEST	Jan 26, 1998	Substantially Equivalent	PHAMATECH
K974851	SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST	Jan 22, 1998	Substantially Equivalent	SAN DIEGO BIOTECH
K974159	OSOM HCG-URINE TEST MODEL 101	Dec 24, 1997	Substantially Equivalent	WYNTEK DIAGNOSTICS, INC.
K974052	QUICKVUE SEMI-Q HCG-COMBO	Dec 19, 1997	Substantially Equivalent	QUIDEL CORP.
K973957	DBEST ONE-STEP HCG SERUM/URINE TEST	Dec 17, 1997	Substantially Equivalent	AMERITEK, INC.
K973841	QUICKVUE ONE-STEP HCG-COMBO	Dec 01, 1997	Substantially Equivalent	QUIDEL CORP.
K973858	CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO	Nov 26, 1997	Substantially Equivalent	QUIDEL CORP.
K973879	OSOM CARD HCG-URINE TEST	Nov 04, 1997	Substantially Equivalent	WYNTEK DIAGNOSTICS, INC.
K972748	CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE	Aug 29, 1997	Substantially Equivalent	QUIDEL CORP.
K972742	QUICKVUE ONE-STEP HCG-URINE	Aug 29, 1997	Substantially Equivalent	QUIDEL CORP.
K971886	ACCUTEST HCG-URINE	Jun 11, 1997	Substantially Equivalent	UNOTECH DIAGNOSTICS, INC.
K971122	ACCULINE PREGNANCY TEST	Apr 25, 1997	Substantially Equivalent	GENIX BIOTEK, INC.
K971209	CLINITEK HCG TEST STRIPS	Apr 04, 1997	Substantially Equivalent	BAYER CORP.
K970424	EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST	Mar 06, 1997	Substantially Equivalent	EXCEL SCIENTIFIC, INC.
K965116	ABBOTT TESTPACK PLUS HCG COMBO WITH OBC	Feb 20, 1997	Substantially Equivalent	ABBOTT LABORATORIES
K964633	ACCUPACK PREGNANCY TEST	Feb 20, 1997	Substantially Equivalent	GENIX BIOTEK, INC.
K965253	SAS PREGNANCY STRIP	Feb 18, 1997	Substantially Equivalent	SASCIE
K965250	SAS SERUM/URINE HCG	Feb 18, 1997	Substantially Equivalent	SASCIE
K964536	ONE-STEP DIPSTICK PREGNANCY TEST	Feb 11, 1997	Substantially Equivalent	TECO DIAGNOSTICS
K964462	ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST	Feb 11, 1997	Substantially Equivalent	TECO DIAGNOSTICS
K964461	ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST	Feb 11, 1997	Substantially Equivalent	TECO DIAGNOSTICS
K965227	OSOM CLASSIC HCG-URINE TEST (115)	Feb 04, 1997	Substantially Equivalent	WYNTEK DIAGNOSTICS, INC.
K964995	SAS ONE-STEP PREGNANCY	Jan 21, 1997	Substantially Equivalent	SA SCIENTIFIC, INC.
K964574	AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST	Jan 21, 1997	Substantially Equivalent	ATHENA MEDICAL CORP.
K963231	EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST	Dec 04, 1996	Substantially Equivalent	EXCEL SCIENTIFIC, INC.
K964156	CONTRAST STRIP HCG	Nov 25, 1996	Substantially Equivalent	GENZYME DIAGNOSTICS
K964155	CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST	Nov 25, 1996	Substantially Equivalent	GENZYME DIAGNOSTICS
K963133	PS-UNIT CASSETTE/SERUM HCG	Nov 18, 1996	Substantially Equivalent	INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K963132	MINI STRIP/SERUM HCG	Nov 18, 1996	Substantially Equivalent	INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K963408	VISUALINE D HCG	Oct 18, 1996	Substantially Equivalent	SUN BIOMEDICAL LABORATORIES, INC.
K962906	SCRIPPS LABORATORIES HCG ONE-STEP	Aug 23, 1996	Substantially Equivalent	SCRIPPS LABORATORIES, INC.
K954065	BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT	Jul 10, 1996	Substantially Equivalent	BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
K961911	DSL ACTIVE I-HCG ELISA	Jun 28, 1996	Substantially Equivalent	DIAGNOSTIC SYSTEMS LABORATORIES, INC.
K960357	DSL ACTIVE I-HCG IRMA	May 07, 1996	Substantially Equivalent	DIAGNOSTIC SYSTEMS LABORATORIES, INC.
K960992	BIONIKE A/Q PREGNANCY TEST	Apr 25, 1996	Substantially Equivalent	BIONIKE LABORATORIES, INC.
K955353	ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT	Mar 19, 1996	Substantially Equivalent	TCPI, INC.
K955266	ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT	Feb 29, 1996	Substantially Equivalent	BOEHRINGER MANNHEIM ITALIA SPA
K953486	MIT ONE STEP PREGNANCY TEST	Dec 21, 1995	Substantially Equivalent	3C DIAGNOSTICS, INC.
K954993	QUIX RAPID PREGNANCY STRIP TEST	Dec 13, 1995	Substantially Equivalent	GUARDIAN SCIENTIFIC, CORP.
K954901	BIONIKE A/Q PREGNANCY TEST	Dec 11, 1995	Substantially Equivalent	BIONIKE LABORATORIES, INC.
K954732	ACCESS TOTAL BHCG ASSAY (MODIFICATION)	Nov 20, 1995	Substantially Equivalent	BIO-RAD LABORATORIES, INC.
K954273	CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG	Oct 16, 1995	Substantially Equivalent	QUIDEL CORP.
K954029	TESTPACK PLUS HCG URINE	Oct 05, 1995	Substantially Equivalent	ABBOTT LABORATORIES
K951705	MINISTRIP HCG	Oct 03, 1995	Substantially Equivalent	INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K953383	WYNTEK OSOM HCG-URINE TEST	Aug 29, 1995	Substantially Equivalent	WYNTEK DIAGNOSTICS, INC.
K952319	CONTRAST & RAPID HCG URINE/SERUM TST	Jun 20, 1995	Substantially Equivalent	MEDIX BIOTECH, INC.
K951136	BIONIKE A/Q PREGNANCY TEST	Apr 20, 1995	Substantially Equivalent	CHARLTON ASSOC.
K943859	QUICK CHECKER HCG PREGNANCY TEST	Feb 10, 1995	Substantially Equivalent	MIZUHO USA, INC.
K945951	QUIKPAC II, ONE STEP HCG COMBO KIT	Feb 08, 1995	Substantially Equivalent	SYNTRON BIORESEARCH, INC.
K945969	RAPIDVUE(TM) HCG	Jan 27, 1995	Substantially Equivalent	QUIDEL CORP.
K943239	VISUALINE II HCG	Dec 07, 1994	Substantially Equivalent	SUN BIOMEDICAL LABORATORIES, INC.
K944426	BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE	Oct 25, 1994	Substantially Equivalent	PRINCETON BIOMEDITECH CORP.
K942464	UC QIK 1-STEP HCG TEST	Sep 20, 1994	Substantially Equivalent	EUCARDIO LABORATORY, INC.
K935673	AXSYM TOTAL B-HCG	Jun 21, 1994	Substantially Equivalent	ABBOTT LABORATORIES
K936031	ONE STEP PREGNANCY TEST	Apr 15, 1994	Substantially Equivalent	TECO DIAGNOSTICS
K936287	KODAK SURECELL HCG URINE TEST, MODIFICATION	Apr 08, 1994	Substantially Equivalent	EASTMAN KODAK COMPANY
K936138	KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION	Apr 08, 1994	Substantially Equivalent	EASTMAN KODAK COMPANY
K935502	EVENT TEST STRIP HCG	Jan 27, 1994	Substantially Equivalent	BOEHRINGER MANNHEIM ITALIA SPA
K931698	KINGS BAY PRELUDE ONE STEP HCG COMBO KIT	Nov 05, 1993	Substantially Equivalent	KING'S BAY INTL., INC.
K932758	MEDIX BIOTECH BESTEST HCG-URINE TEST KIT	Sep 28, 1993	Substantially Equivalent	MEDIX BIOTECH, INC.
K932279	OPUS(R) TOTAL B-HCG TEST SYSTEM	Jul 08, 1993	Substantially Equivalent	PB DIAGNOSTIC SYSTEMS, INC.
K932042	QUICKVUE ONE-STEP HCG COMBO	Jun 29, 1993	Substantially Equivalent	QUIDEL CORP.
K925303	PRO-STEP PT HCG	Jun 15, 1993	Substantially Equivalent	DISEASE DETECTION INTERNATIONAL, INC.
K931302	SAS PREGNANCY STRIP	Jun 09, 1993	Substantially Equivalent	SA SCIENTIFIC, INC.
K926500	UC QIK PREGNANCY TEST	Jun 07, 1993	Substantially Equivalent	EUCARDIO LABORATORY, INC.
K924673	CLEARVIEW HCG	May 11, 1993	Substantially Equivalent	UNIPATH LTD.
K930014	PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST	Mar 25, 1993	Substantially Equivalent	VANGUARD BIOMEDICAL CORP.
K925277	CIBA CORNING ACS HCG IMMUNOASSAY	Mar 19, 1993	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K926356	PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG	Mar 18, 1993	Substantially Equivalent	BECTON DICKINSON ADVANCED DIAGNOSTICS
K926342	VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY	Feb 17, 1993	Substantially Equivalent	SYVA CO.
K926198	ACCESS TOTAL BHCG ASSAY	Feb 08, 1993	Substantially Equivalent	BIO-RAD LABORATORIES, INC.
K926204	SAS ONE STEP PREGNANCY	Feb 02, 1993	Substantially Equivalent	SA SCIENTIFIC, INC.
K925125	PRO-STEP HCG	Jan 13, 1993	Substantially Equivalent	DISEASE DETECTION INTERNATIONAL, INC.
K923925	HCG STAT-PAK	Dec 24, 1992	Substantially Equivalent	Chembio Diagnostic Systems, Inc.
K925435	QUICKVUE ONE-STEP HCG TEST	Dec 03, 1992	Substantially Equivalent	QUIDEL CORP.
K924259	MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100	Nov 25, 1992	Substantially Equivalent	MEDIX BIOTECH, INC.
K923376	VISUAL HCG PREGNANCY TEST	Oct 01, 1992	Substantially Equivalent	TECH-CO, INC.
K923030	ANI BIOCARD HCG TEST	Sep 15, 1992	Substantially Equivalent	ANI OY
K923123	HCG PREGNANCY ONE STEP TEST STRIP	Sep 09, 1992	Substantially Equivalent	TCPI, INC.
K922697	DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD	Aug 10, 1992	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K921302	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM	Jul 28, 1992	Substantially Equivalent	VITEK SYSTEMS, INC.
K922290	SINGLE-STEP PREGNANCY, HCG TEST	Jul 09, 1992	Substantially Equivalent	AMERICAN MEDICAL PRODUCTS, INC.
K921212	MIRCO ELISA HPL TEST KIT	May 07, 1992	Substantially Equivalent	BIO CLINIC CO.
K921211	NOW PREGNANCY TEST KIT	May 07, 1992	Substantially Equivalent	BIO CLINIC CO.
K920918	TMB CHROMOGEN/SUBSTRATE REAGENT SET	Apr 07, 1992	Substantially Equivalent	BIO CLINIC CO.
K920505	AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR	Mar 23, 1992	Substantially Equivalent	EASTMAN KODAK COMPANY
K920253	MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT	Feb 14, 1992	Substantially Equivalent	MEDIX BIOTECH, INC.
K915701	KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION	Jan 27, 1992	Substantially Equivalent	EASTMAN KODAK COMPANY
K915197	PRECISE TM HCG	Dec 17, 1991	Substantially Equivalent	BECTON DICKINSON ADVANCED DIAGNOSTICS
K915200	PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA	Dec 16, 1991	Substantially Equivalent	BECTON DICKINSON ADVANCED DIAGNOSTICS
K914696	MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011	Nov 13, 1991	Substantially Equivalent	MEDIX BIOTECH, INC.
K914240	CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF	Oct 25, 1991	Substantially Equivalent	UNIPATH LTD.
K914303	TARGET(TM)-HOG	Oct 11, 1991	Substantially Equivalent	V-TECH, INC.
K914253	PROCLINIC ONE STEP PREGNANCY TEST	Oct 11, 1991	Substantially Equivalent	VANGUARD BIOMEDICAL CORP.
K913122	DIRECTIGEN 1-2-3(TM) HCG TEST	Aug 16, 1991	Substantially Equivalent	QUIDEL CORP.
K911826	IMMUNOCARD HCG ONE STEP (I-S) TEST KIT	Jul 19, 1991	Substantially Equivalent	DISEASE DETECTION INTERNATIONAL, INC.
K912535	IMX TOTAL B-HCG	Jul 01, 1991	Substantially Equivalent	ABBOTT LABORATORIES
K912534	IMX HCG	Jul 01, 1991	Substantially Equivalent	ABBOTT LABORATORIES
K911047	OBA(TM) SERUM HCG ASSAY	Jun 24, 1991	Substantially Equivalent	ADEZA BIOMEDICAL
K905741	CLEARVIEW HCG SERUM/URINE	May 15, 1991	Substantially Equivalent	UNIPATH LTD.
K910349	IMMUNOCORP COATED TUBE IRMA HCG	Mar 21, 1991	Substantially Equivalent	IMMUNOCORP
K910420	BIOCLONE'S ELEGANCE HCG ELISA KIT	Feb 26, 1991	Substantially Equivalent	BIOCLONE AUSTRALIA PTY LTD.
K903937	TARGET(TM) HOG ONE STEP	Oct 22, 1990	Substantially Equivalent	V-TECH, INC.
K904016	MAXI TEST	Oct 15, 1990	Substantially Equivalent	BHC BIOTECH LTD.
K904123	CIBA CORNING ACS HCG IMMUNOASSAY	Oct 03, 1990	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K903219	ABBOTT TESTPACK PLUS TM HCG-COMBO	Sep 25, 1990	Substantially Equivalent	ABBOTT LABORATORIES
K902720	AFFINITY HCG TEST SYSTEM	Aug 09, 1990	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K902681	EZ-SCREEN:HCG	Aug 09, 1990	Substantially Equivalent	ENVIRONMENTAL DIAGNOSTICS, INC.
K902136	KODAK SURECELL(TM) HCG-URINE TEST KIT	Jun 28, 1990	Substantially Equivalent	EASTMAN KODAK COMPANY
K901935	OPUS (TM) HCG	Jun 26, 1990	Substantially Equivalent	PB DIAGNOSTIC SYSTEMS, INC.
K901011	BIOSIGN HCG-ONE STEP PREGNANCY TEST	May 04, 1990	Substantially Equivalent	PRINCETON BIOMEDIX
K901484	LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC	May 01, 1990	Substantially Equivalent	LONDON DIAGNOSTICS, INC.
K900327	IMX HCG (LIST #03A63)	Apr 18, 1990	Substantially Equivalent	ABBOTT LABORATORIES
K901045	HCG SOLID PHASE COMPONENT SYSTEM	Mar 29, 1990	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K896587	MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT	Feb 16, 1990	Substantially Equivalent	MEDIX BIOTECH, INC.
K896901	ENZYMUN TEST R HCG	Feb 08, 1990	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K894175	SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY	Dec 19, 1989	Substantially Equivalent	SERONO-BAKER DIAGNOSTICS, INC.
K895912	IMMUNOCARD HCG II-S TEST KIT	Dec 01, 1989	Substantially Equivalent	DISEASE DETECTION INTERNATIONAL, INC.
K895809	MILENIA(TM) HCG (MKCG1,5)	Dec 01, 1989	Substantially Equivalent	DIAGNOSTIC PRODUCTS CORP.
K895390	CARDS O.S. (TM) HCG-URINE	Nov 13, 1989	Substantially Equivalent	PACIFIC BIOTECH, INC.
K894941	COAT-A-COUNT (TM) HCG IRMA	Oct 25, 1989	Substantially Equivalent	DIAGNOSTIC PRODUCTS CORP.
K894790	QUIDEL HCG TEST	Oct 25, 1989	Substantially Equivalent	QUIDEL CORP.
K894750	BIOSTIX I. HCG - ONE STEP PREGNANCY TEST	Oct 18, 1989	Substantially Equivalent	PRINCETON BIOMEDIX
K894705	BIOSPOT HCG-RAPID PREGNANCY TEST	Oct 18, 1989	Substantially Equivalent	PRINCETON BIOMEDIX
K894420	ORTHO RESULT PLUS/PREGNANCY	Oct 04, 1989	Substantially Equivalent	ORTHO DIAGNOSTIC SYSTEMS, INC.
K894182	IMX TOTAL B-HCG	Sep 26, 1989	Substantially Equivalent	ABBOTT LABORATORIES
K894408	ABBOTT TESTPACK PLUS HCG URINE	Sep 05, 1989	Substantially Equivalent	ABBOTT LABORATORIES
K894012	MINICLINIC PREGNANCY TEST	Jul 25, 1989	Substantially Equivalent	VANGUARD BIOMEDICAL CORP.
K891770	HCG IRMA II	May 24, 1989	Substantially Equivalent	PACIFIC BIOTECH, INC.
K890615	DIRECTIGEN1-2-3 BHCG PREGNANCY TEST	Apr 18, 1989	Substantially Equivalent	QUIDEL CORP.
K890549	VENTREX COATED TUBE HCG	Mar 28, 1989	Substantially Equivalent	VENTREX LABORATORIES, INC.
K890131	TARGET(TM) QUANTITATIVE HCG	Mar 09, 1989	Substantially Equivalent	V-TECH, INC.
K884880	PREGNAGEN(TM)	Jan 13, 1989	Substantially Equivalent	BIOGENEX LABORATORIES
K884616	FIRSTDAY EARLY PREGNANCY TESTING KIT II	Jan 13, 1989	Substantially Equivalent	PACIFIC BIOTECH, INC.
K883927	CIBA CORNING MAGIC LITE HCG IMMUNOASSAY	Oct 13, 1988	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K883777	CLEARVIEW HCG	Oct 06, 1988	Substantially Equivalent	UNIPATH LTD.
K883639	MODIFIED HCG IRMA KIT	Oct 06, 1988	Substantially Equivalent	PACIFIC BIOTECH, INC.
K882002	PREGNAGEN(TM)	Sep 09, 1988	Substantially Equivalent	BIOGENEX LABORATORIES
K881015	FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT	Aug 29, 1988	Substantially Equivalent	PACIFIC BIOTECH, INC.
K882155	COTUBE HCG IRMA TEST	Aug 08, 1988	Substantially Equivalent	BIO-RAD
K881806	QLT ABSOLUTE URINE-HCG PREGNANCY TEST	Aug 02, 1988	Substantially Equivalent	QUADRA LOGIC TECHNOLOGIES, INC.
K882086	QTEST(TM) PREGNANCY	Jul 28, 1988	Substantially Equivalent	QUIDEL CORP.
K881709	IMMUNOCARD(TM) HCG II TEST KIT	Jul 08, 1988	Substantially Equivalent	DISEASE DETECTION INTERNATIONAL, INC.
K881355	AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT	Jun 08, 1988	Substantially Equivalent	AMERSHAM CORP.
K881595	QUIDEL PREGNANCY TEST	May 27, 1988	Substantially Equivalent	QUIDEL CORP.
K881005	IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG	May 27, 1988	Substantially Equivalent	ICN BIOMEDICALS, INC.
K880410	HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT	Apr 05, 1988	Substantially Equivalent	DISEASE DETECTION INTERNATIONAL, INC.
K880070	ABBOTT IMX HCG	Mar 24, 1988	Substantially Equivalent	ABBOTT LABORATORIES
K880577	CONCEP-7-BHCG	Mar 15, 1988	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K874388	KODAK SURECELL(TM) HCG-URINE KIT	Feb 08, 1988	Substantially Equivalent	EASTMAN KODAK COMPANY
K874033	IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X	Jan 05, 1988	Substantially Equivalent	DIAGNOSTIC PRODUCTS CORP.
K874258	VENTRESCREEN, HCG URINE	Nov 23, 1987	Substantially Equivalent	VENTREX LABORATORIES, INC.
K873788	CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504	Nov 23, 1987	Substantially Equivalent	PACIFIC BIOTECH, INC.
K872730	RESULT PLUS/HCG PREGNANCY TEST	Oct 20, 1987	Substantially Equivalent	ORTHO DIAGNOSTIC SYSTEMS, INC.
K873524	AFFINITY HCG IMMUNIT (POLYCLONAL)	Oct 06, 1987	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K873033	HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE	Sep 14, 1987	Substantially Equivalent	SERONO DIAGNOSTICS, INC.
K872390	ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM	Sep 02, 1987	Substantially Equivalent	NICHOLS INSTITUTE DIAGNOSTICS
K872728	BINAX IRMA TOTAL BETA-HCG TEST KIT	Aug 05, 1987	Substantially Equivalent	BINAX, INC.
K872130	ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES	Jul 16, 1987	Substantially Equivalent	SYVA CO.
K871700	HCG MAB SOLID PHASE COMPONENT SYSTEM	Jul 15, 1987	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K871308	ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT	Jun 11, 1987	Substantially Equivalent	ALLELIX, INC.
K871235	TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT	Jun 03, 1987	Substantially Equivalent	HYBRITECH, INC.
K870627	AFFINITY (TM) HCG IMMUNIT (TM)	May 28, 1987	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K870751	SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST	May 20, 1987	Substantially Equivalent	SYNTRON BIORESEARCH, INC.
K870739	ABBOTT TESTPACK HCG COMBO	May 20, 1987	Substantially Equivalent	ABBOTT LABORATORIES
K870521	TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY	Apr 08, 1987	Substantially Equivalent	HYBRITECH, INC.
K870672	ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD	Apr 01, 1987	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K870106	COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS	Mar 13, 1987	Substantially Equivalent	DIAGNOSTIC PRODUCTS CORP.
K864174	UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE	Mar 13, 1987	Substantially Equivalent	UNITED BIOTECH, INC.
K870259	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	Mar 10, 1987	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K865057	TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY	Mar 10, 1987	Substantially Equivalent	HYBRITECH, INC.
K865076	SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST	Feb 11, 1987	Substantially Equivalent	SYNTRON BIORESEARCH, INC.
K864591	HCG SOLID PHASE COMPONENT SYSTEM	Feb 04, 1987	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K863933	VIS-CUBE HCG (EIA)	Dec 15, 1986	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K863861	TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA	Nov 21, 1986	Substantially Equivalent	HYBRITECH, INC.
K863199	CARDS(TM) HCG-URINE	Sep 15, 1986	Substantially Equivalent	PACIFIC BIOTECH, INC.
K863032	ABBOTT TESTPACK (TM) HCG SERUM	Sep 15, 1986	Substantially Equivalent	ABBOTT LABORATORIES
K862262	HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS	Jul 29, 1986	Substantially Equivalent	SERONO DIAGNOSTICS, INC.
K862247	TARGET HCG, ENZYME IMMUNOASSAY REAGENTS	Jul 29, 1986	Substantially Equivalent	V-TECH, INC.
K862007	HCG IRMA, CAT. NO. CR-1501	Jul 01, 1986	Substantially Equivalent	PACIFIC BIOTECH, INC.
K860965	BETA QUIK STICK	Apr 24, 1986	Substantially Equivalent	PACIFIC BIOTECH, INC.
K860542	TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT	Mar 05, 1986	Substantially Equivalent	HYBRITECH, INC.
K860490	MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY	Mar 05, 1986	Substantially Equivalent	MEDIX BIOTECH, INC.
K854958	HCG RIA TEST SYSTEM	Jan 28, 1986	Substantially Equivalent	MONOBIND
K854989	CANWEST-PREGBLUE	Jan 13, 1986	Substantially Equivalent	CANWEST MEDICTEX, INC.
K854059	MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO	Jan 13, 1986	Substantially Equivalent	BIOCLINICAL SYSTEMS, INC.
K854611	RAMP URINE HCG ASSAY	Dec 30, 1985	Substantially Equivalent	MONOCLONAL ANTIBODIES, INC.
K854104	IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)	Dec 05, 1985	Substantially Equivalent	IMMUNCHEM CORP.
K852760	LBK 1244 DELFIA HCG KIT	Dec 05, 1985	Substantially Equivalent	LKB INSTRUMENTS, INC.
K853925	QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA	Dec 02, 1985	Substantially Equivalent	NMS PHARMACEUTICALS, INC.
K854024	CORNING MAGIC MAB HCG RADIOIMMUNOASSAY	Nov 26, 1985	Substantially Equivalent	CORNING MEDICAL & SCIENTIFIC
K853748	VENTRESCREEN HCG URINE	Oct 01, 1985	Substantially Equivalent	VXR, INC.
K853258	BETA-HCG MICROTITER PREGNANCY TEST	Oct 01, 1985	Substantially Equivalent	MODERN DIAGNOSTICS, INC.
K853539	ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT	Sep 25, 1985	Substantially Equivalent	ABBOTT LABORATORIES
K853006	HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY	Sep 04, 1985	Substantially Equivalent	MODERN DIAGNOSTICS, INC.
K852327	BETA QUIK STAT	Aug 20, 1985	Substantially Equivalent	PACIFIC BIOTECH, INC.
K852675	AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT	Jul 22, 1985	Substantially Equivalent	AMERSHAM CORP.
K852437	VISUAL SERUM/URINE HCG COMBO KIT	Jul 12, 1985	Substantially Equivalent	AMERICAN BIOCLINICAL, INC.
K852183	BETA HCG EXTENDED RANGE ACCESSORY KIT	Jul 09, 1985	Substantially Equivalent	ABBOTT LABORATORIES
K852201	ECHOCLONAL HCG IRMA	Jun 28, 1985	Substantially Equivalent	BIO-RAD
K850727	BHCG-ROCHE EIA	Jun 25, 1985	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K851076	UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST	May 10, 1985	Substantially Equivalent	UNITED BIOTECH, INC.
K850992	PREGNA-ZYME	May 01, 1985	Substantially Equivalent	ARMKEL, LLC.
K850949	MEDIX VISUAL URINE HCG (7/7) TEST	Apr 12, 1985	Substantially Equivalent	MEDIX BIOTECH, INC.
K850987	MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM	Apr 08, 1985	Substantially Equivalent	MEDIX BIOTECH, INC.
K850730	MODEL SERUM HCG ASSAY	Apr 02, 1985	Substantially Equivalent	MONOCLONAL ANTIBODIES, INC.
K850570	STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY	Apr 02, 1985	Substantially Equivalent	AMERICAN DADE
K850531	LEECO CONCEP-7-BHCG EIA	Apr 02, 1985	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K850530	LEECO CONCEP-7-BHCG IRMA	Apr 02, 1985	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K850201	LEECO CONCEP-7-BHCG LEIAD II	Mar 04, 1985	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K850159	TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT	Mar 04, 1985	Substantially Equivalent	HYBRITECH, INC.
K844153	CONCEP-7-BHCG (EIA)	Dec 14, 1984	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K844082	QUEST BETA HCG ENZYME IMMUNOASSAY KIT	Nov 21, 1984	Substantially Equivalent	QUIDEL CORP.
K843795	BETA QUIK V	Oct 30, 1984	Substantially Equivalent	PACIFIC BIOTECH, INC.
K843407	ENCORE HCG REAGENT	Oct 04, 1984	Substantially Equivalent	HYBRITECH, INC.
K842654	EPSILON HCG TEST KIT MONOCLONAL	Oct 01, 1984	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K842499	NMS 1043 ENZYME IMMUNOASSAY KIT	Sep 14, 1984	Substantially Equivalent	NMS PHARMACEUTICALS, INC.
K842692	QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT	Sep 05, 1984	Substantially Equivalent	QUIDEL CORP.
K842633	TANDEM FAST VISUAL HCG ASSAY KIT -	Aug 23, 1984	Substantially Equivalent	HYBRITECH, INC.
K842598	STAR HCG MONOCLONAL ANTIBODY IMMUNO	Jul 26, 1984	Substantially Equivalent	SYNCOR INTL. CORP.
K841854	BHCG RIA	Jun 22, 1984	Substantially Equivalent	SYNCOR INTL. CORP.
K841821	CA-1511, IN VITRO RADIOIMMUNOASSAY	Jun 22, 1984	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K841525	OREIA II B-HCG PREGNANCY TEST KIT	Jun 05, 1984	Substantially Equivalent	ORGANON, INC.
K841081	VENTREZYME BETA-HCG IMMUNOASSAY HCG	May 07, 1984	Substantially Equivalent	VENTREX LABORATORIES, INC.
K841023	COATED TUBE HCG IMMUNOASSAY HCG	May 01, 1984	Substantially Equivalent	VENTREX LABORATORIES, INC.
K840328	PHASE II HCG KIT	Apr 19, 1984	Substantially Equivalent	MEDICAL & SCIENTIFIC DESIGNS, INC.
K833851	HCG RIA	Mar 19, 1984	Substantially Equivalent	SYNCOR INTL. CORP.
K834000	TANDEM VISUAL HCG IMMUNOENZYMETRIC	Feb 03, 1984	Substantially Equivalent	HYBRITECH, INC.
K833960	VENTREX PREGNANCY TEST KIT ENZYME	Feb 03, 1984	Substantially Equivalent	VXR, INC.
K832796	STAR HCG MONOCLONAL ANTIBODY IMMUNORAD	Jan 24, 1984	Substantially Equivalent	SYNCOR INTL. CORP.
K833194	TANDEM R-TOTAL B-GCG KIT	Jan 18, 1984	Substantially Equivalent	HYBRITECH, INC.
K832801	OREIA II B-HCG, ENZYME INNUNOASSAY	Dec 08, 1983	Substantially Equivalent	ORGANON, INC.
K832892	MODIFIED CHORIO-SHURE	Oct 28, 1983	Substantially Equivalent	NUCLEAR MEDICAL LABORATORIES, INC.
K832562	SERUM HCG ASSAY	Sep 12, 1983	Substantially Equivalent	MONOCLONAL ANTIBODIES, INC.
K831604	HCG ACCU-STICK	Jul 19, 1983	Substantially Equivalent	BTC DIAGNOSTICS, INC.
K831302	PBI BHCG RIA KIT	Jun 08, 1983	Substantially Equivalent	PACIFIC BIOTECH, INC.
K831264	BHCG RIA KIT	Jun 08, 1983	Substantially Equivalent	MICROMEDIC SYSTEMS
K831223	BETA-QUIK-15 RIA KIT	Jun 02, 1983	Substantially Equivalent	PACIFIC BIOTECH, INC.
K831221	RIAGEN B-HCG RIA KIT	Jun 02, 1983	Substantially Equivalent	BIO GENEX LABORATORIES
K831109	DUOCLON SLIDE TEST	Jun 02, 1983	Substantially Equivalent	ORGANON, INC.
K830997	ARIA II I-HCG	Jun 02, 1983	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K830526	B-GCG SYSTEM BY RIA	Apr 05, 1983	Substantially Equivalent	PCL-RIA, INC.
K830695	BETA-COTE B-HCG PREGNANCY SCREENING SYS	Mar 29, 1983	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K830203	DAC-CEL DIAGNATAL RD 50	Feb 18, 1983	Substantially Equivalent	WELLCOME DIAGNOSTICS
K830138	TANDEM E GCG VISUAL END POINT INNUMOENZ	Feb 07, 1983	Substantially Equivalent	HYBRITECH, INC.
K823753	GENESIS B-HCG	Jan 24, 1983	Substantially Equivalent	ARMKEL, LLC.
K823313	IN VITRO GAMMACOAT B-HCG RADIO. TEST	Dec 22, 1982	Substantially Equivalent	CLINICAL ASSAYS, INC.
K822840	RADIOIMMUNOASSAY, HUMAN CHORRIONIC	Oct 27, 1982	Substantially Equivalent	BIOCLINICAL GROUP
K822520	MODEL UCG ASSAY	Sep 28, 1982	Substantially Equivalent	MONOCLONAL ANTIBODIES, INC.
K822515	B-HCG RADIOIMMUNOASSAY KIT	Sep 14, 1982	Substantially Equivalent	BIOCLINICAL GROUP
K822343	B-HCG	Sep 02, 1982	Substantially Equivalent	DIAGNOSTIC PRODUCTS CORP.
K822152	HCG BETA RIA KIT	Sep 02, 1982	Substantially Equivalent	CLINETICS CORP.
K821944	TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT	Jul 22, 1982	Substantially Equivalent	HYBRITECH, INC.
K821657	RIAGEN B-HCG RIA	Jul 13, 1982	Substantially Equivalent	BIOGENEX LABORATORIES
K821234	RIAGEN B-HCG RIA	May 21, 1982	Substantially Equivalent	BIOGENEX LABORATORIES
K821031	AMERLEX B-LCG RIA KIT	May 03, 1982	Substantially Equivalent	AMERSHAM CORP.
K820942	ROCHE(R) B-HCG RIA URINE STANDARD	May 03, 1982	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K820822	TANDEM HCG KIT	Apr 29, 1982	Substantially Equivalent	HYBRITECH, INC.
K820614	ROCHE B-HCG STANDARDS	Apr 01, 1982	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K820613	ROCHE B-HCG RIA	Apr 01, 1982	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K820523	CHORIO-QUANT	Mar 15, 1982	Substantially Equivalent	NUCLEAR MEDICAL LABORATORIES, INC.
K820321	IMMOPHASE B HCG RADIOIMMUNOASSAY	Mar 11, 1982	Substantially Equivalent	CORNING MEDICAL & SCIENTIFIC
K820271	ABBOTT LABORATORIES B-HCG EIA	Mar 11, 1982	Substantially Equivalent	ABBOTT LABORATORIES
K812461	TANDEM QUALITATIVE HCG KIT	Oct 13, 1981	Substantially Equivalent	HYBRITECH, INC.
K812156	CONCEP-7-BHCG	Aug 20, 1981	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K811421	HCG RADIOIMMUNOASSAY KIT (125I)	Jul 10, 1981	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K811398	EARLY PREGNANCY DETECTION	May 29, 1981	Substantially Equivalent	IMMUCHEM CORP.
K811116	HCG RADIOIMMUNOASSAY	May 13, 1981	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K810936	CHORIO-SHURE	Apr 17, 1981	Substantially Equivalent	NUCLEAR MEDICAL LABORATORIES, INC.
K810215	DAC-CEL HCG	Apr 17, 1981	Substantially Equivalent	BURROUGHS WELLCOME CO.
K810214	DAC-CEL DIAGNATAL	Mar 06, 1981	Substantially Equivalent	BURROUGHS WELLCOME CO.
K802999	BETA-TEC QUALITATIVE	Dec 22, 1980	Substantially Equivalent	ARMKEL, LLC.
K801491	MRI HCG-BETA RIA KIT CAT. #MR-10100	Aug 13, 1980	Substantially Equivalent	MICROANALYTIC RESEARCH, INC.
K801409	GAMMADAB B-HCG RADIOIMMUNOASSAY KIT	Jul 14, 1980	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K801244	ROCHE HCG STANDARDS	Jun 20, 1980	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K792308	CONCEP-7-BHCG	Dec 06, 1979	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K792197	HUMAN CHORIONIC GONADOTROPIN (RIA)	Dec 06, 1979	Substantially Equivalent	NUCLEAR MEDICAL LABORATORIES, INC.
K791206	HCG RIA PREGNANCY TEST	Jul 30, 1979	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K790876	LABELED HUMAN CHORIONIC GONADOTROPHIN	Jul 17, 1979	Substantially Equivalent	PCL-RIA, INC.
K790864	RABBIT ANTISERUM TO HUMAN CHORIONIC	Jul 17, 1979	Substantially Equivalent	PCL-RIA, INC.
K790863	HUMAN CHORIONIC GONADOTROPHIN STANDARDS	Jul 17, 1979	Substantially Equivalent	PCL-RIA, INC.
K790397	CONCEP-7-B-HCG	May 23, 1979	Substantially Equivalent	LEECO DIAGNOSTICS, INC.
K790138	CHORIC-SHURE	Mar 12, 1979	Substantially Equivalent	NUCLEAR MEDICAL LABORATORIES, INC.
K781794	BETA-TEC	Dec 29, 1978	Substantially Equivalent	WAMPOLE LABORATORIES
K781733	RIA KIT, PREG-STAT	Dec 20, 1978	Substantially Equivalent	SERONO LABORATORIES, INC.
K781487	EARLY PREGNANCY DETECTION KIT	Oct 11, 1978	Substantially Equivalent	RADIOASSAY SYSTEMS LABORATORIES, INC.
K781578	RIA QUANT B-HCG TEST KIT	Oct 10, 1978	Substantially Equivalent	MALLINCKRODT CRITICAL CARE
K781310	HUMAN CHORIONIC GONADO.-BETA RIA KIT	Aug 31, 1978	Substantially Equivalent	DIAGNOSTICS BIOCHEM CANADA, INC.
K780679	B-HCG-RIA	Jun 14, 1978	Substantially Equivalent	NUCLEAR MEDICAL SYSTEMS, INC.
K772086	QUANTROLS HCG	Nov 23, 1977	Substantially Equivalent	ORGANON, INC.
K772039	BETA-HCG RIA	Nov 23, 1977	Substantially Equivalent	MONITOR SCIENCE CORP.
K760336	BIOCEPT-G	Nov 12, 1976	Substantially Equivalent	WAMPOLE LABORATORIES

FEI Numbers

This FDA classification entry is associated with 110 FEI numbers. Click on an entry to view related FDA registrations.

1000118544: 16 registrations

1000119795: 30 registrations

1000121039: 40 registrations

1000125596: 34 registrations

1000126037: 19 registrations

1000306617: 379 registrations

1000520007: 28 registrations

1000611339: 35 registrations

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