Product Code: JJE FDA class 1 21 CFR 862.2160

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Clinical Chemistry

This device is a photometric discrete chemistry analyzer used in clinical laboratories to perform automated spectrophotometric measurements of individual samples, enabling quantitative analysis of a wide range of biochemical analytes in patient specimens. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket submission. The product code is JJE, regulated under 21 CFR 862.2160, within the Clinical Chemistry medical specialty.

View on FDA

510(k)s

208

FEI Numbers

180

Registration Numbers

180

Unique Applicants

Years Active

Basic Information

Product Code: JJE
Device Class: FDA class 1
Regulation Number: 862.2160
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

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 208 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K183375	Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode	Feb 12, 2019	Substantially Equivalent	Horiba, Ltd
K133519	CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR	May 16, 2014	Substantially Equivalent	CAROLINA LIQUID CHEMISTRIES CORP.
K130915	XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK	May 15, 2014	Substantially Equivalent	JAS Diagnostics, Inc.
K131554	RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT	Jan 09, 2014	Substantially Equivalent	RANDOX LABORATORIES, LTD.
K130276	DIMENSION EXL WITH LM SYSTEM	Mar 22, 2013	Substantially Equivalent	SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K113253	ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT	May 17, 2012	Substantially Equivalent	ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
K112999	DIMENSION CLINICAL CHEMISTRY SYSTEM	Nov 22, 2011	Substantially Equivalent	SIEMENS HEALTHCARE DIAGNOSTICS
K110035	INDIKO	Jun 28, 2011	Substantially Equivalent	THERMO FISHER SCIENTIFIC OY
K073370	TC MATRIX CLINICAL CHEMISTRY ANALYZER	May 08, 2008	Substantially Equivalent	TECO DIAGNOSTICS
K063144	VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM	Nov 13, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K051087	DIMENSION VISTA INTEGRATED SYSTEM	Jul 11, 2005	Substantially Equivalent	DADE BEHRING, INC.
K042169	STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER	Mar 14, 2005	Substantially Equivalent	STANBIO LABORATORY
K040958	PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240	Feb 15, 2005	Substantially Equivalent	TOKYO BOEKI MEDICAL SYSTEM LTD.
K023764	UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100	Jan 28, 2003	Substantially Equivalent	BECKMAN COULTER, INC.
K010500	AUTOMATED WORKCELL CONTROL SOFTWARE	Aug 01, 2001	Substantially Equivalent	LAB-INTERLINK, INC.
K003721	MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	Dec 18, 2000	Substantially Equivalent	OLYMPUS AMERICA, INC.
K002982	OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	Oct 25, 2000	Substantially Equivalent	OLYMPUS AMERICA, INC.
K983345	BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY	Dec 07, 1998	Substantially Equivalent	BAYER CORP.
K974779	ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER	Feb 13, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K974651	ABBOTT AXSYM SYSTEM	Feb 12, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K971761	PERSONALLAB AUTOMATED MICROPLATE ANALYZER	Jul 22, 1997	Substantially Equivalent	BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
K970227	IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER	Apr 08, 1997	Substantially Equivalent	DPC CIRRUS
K965240	SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L	Mar 10, 1997	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K961142	STRATEC LIA II ANALYZER	Feb 18, 1997	Substantially Equivalent	NICHOLS INSTITUTE DIAGNOSTICS
K963539	SIGMA DIAGNOSTICS WASH CONCENTRATE	Dec 16, 1996	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K962231	COBAS CORE IMMUNOCHEMISTRY SYSTEM	Aug 30, 1996	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K962125	TECHNICON IMMUNO 1 SYSTEM	Aug 02, 1996	Substantially Equivalent	BAYER CORP.
K961274	OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER	Jul 05, 1996	Substantially Equivalent	OLYMPUS AMERICA, INC.
K962235	VITROS SPECIALTY DILUENT	Jun 26, 1996	Substantially Equivalent	JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K961481	ELECSYS 2010 ANALYZER	Jun 14, 1996	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K953239	BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER	Sep 25, 1995	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K942922	SELECTA 20/60 CHEMISTRY ANALYZER	Jul 19, 1995	Substantially Equivalent	SELECT MEDICAL SYSTEMS, INC.
K951189	SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0	Jun 13, 1995	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K945566	ABBOTT PROJECT I, SPECTRUM	Jun 09, 1995	Substantially Equivalent	ABBOTT LABORATORIES
K950915	ABBOTT AXSYM II SYSTEM	May 16, 1995	Substantially Equivalent	ABBOTT LABORATORIES
K950958	SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)	May 08, 1995	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K950353	TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM	Apr 20, 1995	Substantially Equivalent	MILES, INC.
K945271	ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM	Apr 20, 1995	Substantially Equivalent	BIO-CHEM LABORATORY SYSTEMS, INC.
K945135	MICROPLATE PROCESSOR 3000	Mar 03, 1995	Substantially Equivalent	ORGANON TEKNIKA CORP.
K943493	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	Jan 30, 1995	Substantially Equivalent	HAMILTON CO.
K946090	KODAK EKTACCHEM 950IRC ANALYZER	Jan 17, 1995	Substantially Equivalent	CLINICAL DIAGNOSTIC SYSTEMS, INC.
K944028	PROCHEM CHEMISTRY ANALYZER	Nov 30, 1994	Substantially Equivalent	PRISMA SYSTEMS
K944093	DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM	Nov 10, 1994	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K942364	HITACHI 914 ANALYZER	Oct 04, 1994	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K942443	AURAFLEX SYSTEMS	Aug 26, 1994	Substantially Equivalent	ORGANON TEKNIKA CORP.
K940289	ABBOTT PRISM ANALYZER	Jul 18, 1994	Substantially Equivalent	ABBOTT MFG., INC.
K940810	CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF	May 23, 1994	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K933703	SIGMA WASH CONCENTRATE SOLUTION	Dec 10, 1993	Substantially Equivalent	SIGMA CHEMICAL CO.
K933548	ELS 1000	Oct 29, 1993	Substantially Equivalent	BIO-TEK INSTRUMENTS, INC.
K931786	ACE CLINICAL CHEMISTRY SYSTEM	Sep 21, 1993	Substantially Equivalent	SCHIAPPARELLI BIOSYSTEMS, INC.
K931744	OLYMPUS REPLY GLUCOSE REAGENT	Aug 31, 1993	Substantially Equivalent	OLYMPUS CORP.
K930489	AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS	May 12, 1993	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K926060	SYNCHRON CX5CE CLINICAL ANALYZER	Feb 12, 1993	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K923579	MINIVIDAS INSTRUMENT	Feb 12, 1993	Substantially Equivalent	BIOMERIEUX VITEK, INC.
K924084	ATAC 6000 CHEMISTRY ANALYZER	Sep 29, 1992	Substantially Equivalent	BIO-CHEM LABORATORY SYSTEMS, INC.
K923060	IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY	Sep 15, 1992	Substantially Equivalent	BECTON DICKINSON ADVANCED DIAGNOSTICS
K922680	DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT	Aug 20, 1992	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K922139	VISTA IMMUNOASSAY SYSTEM -- MODIFICATION	Jul 21, 1992	Substantially Equivalent	SYVA CO.
K922072	KODAK EKTACHEM 250 ANALYER	Jul 10, 1992	Substantially Equivalent	EASTMAN KODAK COMPANY
K921661	BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER	Jun 30, 1992	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K922220	OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER	Jun 25, 1992	Substantially Equivalent	OLYMPUS CORP.
K920402	ROCHE COBAS MIRA PLUS	Apr 29, 1992	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K915366	MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER	Mar 17, 1992	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K915106	DIMENSION AR CLINICAL CHEMISTRY SYSTEM	Jan 28, 1992	Substantially Equivalent	DUPONT MEDICAL PRODUCTS
K912844	KODAK EKTACHEM DTII SYSTEM	Sep 04, 1991	Substantially Equivalent	EASTMAN KODAK COMPANY
K912024	AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)	Jul 19, 1991	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K910185	SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER	Apr 03, 1991	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K904219	SYNCHRON CX 7 CLINICAL ANALYZER	Oct 22, 1990	Substantially Equivalent	BECKMAN
K904220	SYNCHRON CX4-CE	Oct 15, 1990	Substantially Equivalent	BECKMAN
K903071	KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN	Sep 27, 1990	Substantially Equivalent	EASTMAN KODAK COMPANY
K902689	ATAC 6000 CHEMISTRY ANALYZER	Jul 10, 1990	Substantially Equivalent	BIO-CHEM LABORATORIES
K902336	CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE	Jun 18, 1990	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K901346	ES 300 IMMUNOASSAY SYSTEM	Apr 16, 1990	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K901003	BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER	Apr 16, 1990	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K895423	ACCESS CHEMISTRY ANALYZER	Oct 04, 1989	Substantially Equivalent	AMERICAN MONITOR CORP.
K894222	TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL	Sep 28, 1989	Substantially Equivalent	ABBOTT LABORATORIES
K893137	EXCEL (TM) CHEMISTRY ANALYZER	Aug 10, 1989	Substantially Equivalent	AMERICAN MONITOR CORP.
K893776	ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER	Aug 03, 1989	Substantially Equivalent	ABBOTT LABORATORIES
K893547	CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER	Aug 03, 1989	Substantially Equivalent	HERAEUS KULZER, INC.
K890929	KODAK EKTACHEM 750 SERIES ANALYZER	Mar 28, 1989	Substantially Equivalent	EASTMAN KODAK COMPANY
K890928	KODAK EKTACHEM 500 ANALYZER	Mar 28, 1989	Substantially Equivalent	EASTMAN KODAK COMPANY
K890927	KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0	Mar 28, 1989	Substantially Equivalent	EASTMAN KODAK COMPANY
K884378	DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER	Feb 27, 1989	Substantially Equivalent	COULTER CORP.
K885226	TECHNICON AXON(TM) SYSTEM	Feb 17, 1989	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K890184	MODIFIED INTENDED USE OF CLEANING REAGENT KIT	Feb 07, 1989	Substantially Equivalent	HICHEM DIAGNOSTICS
K890183	MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.	Feb 07, 1989	Substantially Equivalent	HICHEM DIAGNOSTICS
K885289	KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0	Feb 07, 1989	Substantially Equivalent	EASTMAN KODAK COMPANY
K885288	HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE	Feb 07, 1989	Substantially Equivalent	EASTMAN KODAK COMPANY
K884035	SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER	Dec 29, 1988	Substantially Equivalent	SCLAVO, INC.
K883533	ABC FP ANALYZER	Dec 15, 1988	Substantially Equivalent	INTL. BIOCLINICAL, INC.
K883539	SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER	Oct 31, 1988	Substantially Equivalent	SERONO-BAKER DIAGNOSTICS, INC.
K883321	CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST	Oct 25, 1988	Substantially Equivalent	HERAEUS KULZER, INC.
K883209	TECHNICON RA-100(TM) SYSTEM	Sep 13, 1988	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K882451	OLYMPUS REPLY CHEMISTRY ANALYZER	Sep 08, 1988	Substantially Equivalent	OLYMPUS CORP.
K882914	VISTA INSTRUMENT	Aug 30, 1988	Substantially Equivalent	ABBOTT LABORATORIES
K882913	DTR ANALYZER	Aug 30, 1988	Substantially Equivalent	ABBOTT LABORATORIES
K882559	PROFILE ONE OMNI	Aug 08, 1988	Substantially Equivalent	MODULAR DIAGNOSTIC SYSTEMS, INC.
K882194	GEMINII GAMMA COUNTER	Aug 04, 1988	Substantially Equivalent	LABORATORY TECHNOLOGIES, INC.
K882307	D-CHEM	Aug 02, 1988	Substantially Equivalent	PHOTEC DIAGNOSTICS, INC.
K882450	GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.	Jul 28, 1988	Substantially Equivalent	DIAMOND SENSOR SYSTEMS
K882081	SPECIFIC CHEMISTRY ANALYZER	Jul 01, 1988	Substantially Equivalent	THE RUPP & BOWMAN CO.
K881498	SYNCHRON CX(TM)4 CLINICAL ANALYZER	Jun 01, 1988	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K881495	SYNCHRON CX(TM)5 CLINICAL ANALYZER	Jun 01, 1988	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K874857	KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0	Feb 08, 1988	Substantially Equivalent	EASTMAN KODAK COMPANY
K873130	WASH SOLUTION KIT	Oct 23, 1987	Substantially Equivalent	A-KEM, INC.
K873749	CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER	Oct 19, 1987	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K873617	GEMSTAR II SYSTEM	Oct 19, 1987	Substantially Equivalent	ELECTRO-NUCLEONICS LABORATORIES, INC.
K872302	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	Sep 08, 1987	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K864849	ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER	Aug 28, 1987	Substantially Equivalent	ANTEK INSTRUMENTS, INC.
K872813	EASY ST ANALYZER SYSTEM	Aug 13, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K872494	HITACHI 717 CHEMISTRY ANALYZER	Jul 09, 1987	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K872105	KODAK EKTACHEM 700XR ANALYZER	Jun 23, 1987	Substantially Equivalent	EASTMAN KODAK COMPANY
K872104	KODAK EKTACHEM 700P ANALYZER	Jun 17, 1987	Substantially Equivalent	EASTMAN KODAK COMPANY
K872103	KODAK EKTACHEM 700S ANALYZER	Jun 17, 1987	Substantially Equivalent	EASTMAN KODAK COMPANY
K870836	ATAC 1500 CHEMISTRY ANALYZER	Apr 01, 1987	Substantially Equivalent	TURPEN LABORATORY SYSTEMS, INC.
K870833	CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY	Apr 01, 1987	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K865105	AFFINITY(TM) SYSTEM	Mar 12, 1987	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K863840	METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM	Nov 05, 1986	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K863531	IQ IMMUNOCHEMISTRY SYSTEM	Oct 20, 1986	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K862235	CIBA CORNING MAGIC LITE ANALYZER	Sep 08, 1986	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K862818	STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY	Aug 19, 1986	Substantially Equivalent	AMERICAN DADE
K861055	EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95	Apr 24, 1986	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K860748	HITACHI 736	Apr 17, 1986	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K860647	ES600 IMMUNOASSAY SYSTEM	Apr 17, 1986	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K860021	DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM	Feb 11, 1986	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K854936	EIA PROCESSOR	Feb 06, 1986	Substantially Equivalent	ABBOTT LABORATORIES
K860080	OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM	Jan 24, 1986	Substantially Equivalent	OLYMPUS CORP.
K855196	CLEANING REAGENT KIT PRODUCT NO 88194	Jan 22, 1986	Substantially Equivalent	HI CHEM, INC.
K853621	REPLACEMENT PUMP TUBING	Dec 05, 1985	Substantially Equivalent	SHABAN MFG. CO.
K854243	ES 22	Nov 19, 1985	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K854138	KODAKEKTACHEM DTR MODULE	Nov 12, 1985	Substantially Equivalent	EASTMAN KODAK COMPANY
K854025	HITACHI 704	Oct 28, 1985	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K853391	MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000	Oct 01, 1985	Substantially Equivalent	EIKEN CHEMICAL CO., INC.
K853699	EASY ANALYZER & EASY-TEST REAGENT	Sep 25, 1985	Substantially Equivalent	DIAGNOSTIC SYSTEMS
K852133	REFLOTRON SYSTEM	Sep 16, 1985	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K853003	HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193	Aug 06, 1985	Substantially Equivalent	HI CHEM, INC.
K852262	ASSIST CLINICAL CHEMISTRY ANALYZER	Jun 25, 1985	Substantially Equivalent	COOPER BIOMEDICAL, INC.
K851638	CLINALYZER MODEL VX-1000	May 13, 1985	Substantially Equivalent	ALPKEM CORP.
K844114	ADD-1	Nov 27, 1984	Substantially Equivalent	ABBOTT LABORATORIES
K843082	ANALOX LM3 MICRO-STAT ANALYSER	Oct 17, 1984	Substantially Equivalent	ANALOX INSTRUMENTS LTD.
K843059	ATAC 2000	Oct 11, 1984	Substantially Equivalent	TURPEN LABORATORY SYSTEMS, INC.
K843610	PERSPECTIVE CHEMICAL ANALYZER	Oct 05, 1984	Substantially Equivalent	AMERICAN MONITOR CORP.
K843283	BOEHRINGER MANNHEIM DIAGNOSTICS ADAM	Oct 05, 1984	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K842773	LABSYSTEMS FP-901 CHEMISTRY ANALYZER	Sep 04, 1984	Substantially Equivalent	LABSYSTEMS, INC.
K842500	DATA MGMT. SYSTEM	Aug 16, 1984	Substantially Equivalent	GILFORD
K841916	ABBOTT PROJECT I	Jun 22, 1984	Substantially Equivalent	ABBOTT LABORATORIES
K841503	KODAK EKTACHEM DT 60 ANALYZER	May 22, 1984	Substantially Equivalent	EASTMAN KODAK COMPANY
K840868	AMRESCO E4A REAGENT SET	May 22, 1984	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K840883	UNIPAK 100 ANALYZER, 65156 & CHEMISTR	May 16, 1984	Substantially Equivalent	EMD CHEMICALS INC.
K841076	ION SELECTIVE ELECTRODE	May 07, 1984	Substantially Equivalent	COOPER BIOMEDICAL, INC.
K840501	ACCULAB SUPPLIES CHEMICAL ANALYZERS	Apr 04, 1984	Substantially Equivalent	PRECISION TECHNOLOGY, INC.
K840129	UNI-FAST ANALYZER SYSTEM	Mar 23, 1984	Substantially Equivalent	SCLAVO, INC.
K840120	ADVANTAGE	Mar 23, 1984	Substantially Equivalent	GILFORD
K834534	APSARA ANALYZER	Mar 09, 1984	Substantially Equivalent	DATACHEM, INC.
K834521	DISCRETE CLINICAL ANALYZER	Feb 27, 1984	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K833833	KODAK EKTACHEM 700 ANALYZER	Jan 17, 1984	Substantially Equivalent	EASTMAN KODAK COMPANY
K832115	ATAC 3000	Jan 10, 1984	Substantially Equivalent	TURPEN LABORATORY SYSTEMS, INC.
K833448	EPOS CHEMISTRY ANALYZER 5060 & 6410	Dec 22, 1983	Substantially Equivalent	EMD CHEMICALS INC.
K833067	IMPACT 400 #1447X2	Dec 08, 1983	Substantially Equivalent	GILFORD
K833116	SPIRIT CHEMISTRY SYSTEM	Nov 07, 1983	Substantially Equivalent	BAKER INSTRUCTIONS CORP.
K832648	ACCLAIM	Sep 20, 1983	Substantially Equivalent	ELECTRO-NUCLEONICS LABORATORIES, INC.
K832584	TUBING KIT 446	Sep 12, 1983	Substantially Equivalent	SHABAN MFG. CO.
K831649	THERMOMIXER S213-PHOTOANALYZER S263	Aug 24, 1983	Substantially Equivalent	TEXAS INTL. LABORATORIES, INC.
K831518	AUTO CAROUSE/WASH SOLUTION CONCENTRATE	Jun 22, 1983	Substantially Equivalent	SYVA CO.
K831477	DEMAND ANALYZER SYSTEM	Jun 17, 1983	Substantially Equivalent	WORTHINGTON DIAGNOSTIC SYSTEMS
K830762	OLYMPUS HIGH SPEED ANALYZER	Apr 12, 1983	Substantially Equivalent	OLYMPUS CORP.
K830212	ELISA PLUS SYSTEM	Apr 05, 1983	Substantially Equivalent	WILLIAM-PALMER INDUSTRIES, INC.
K830318	PARAMAX ANALYTICAL SYS	Mar 07, 1983	Substantially Equivalent	AMERICAN DADE
K830301	STRATUS FLUOROMETRIC ENZYME IMMUN0-	Feb 25, 1983	Substantially Equivalent	AMERICAN HOSPITAL SUPPLY CORP.
K823386	APSARA CLINICAL DIAG. & INFO. SYS	Feb 09, 1983	Substantially Equivalent	DATACHEM, INC.
K823762	VARIOUS-ANALYZER CUPS	Jan 12, 1983	Substantially Equivalent	CORDIS CORP.
K822465	ENZYMUNE SYSTEM I	Sep 14, 1982	Substantially Equivalent	ICL SCIENTIFIC
K821335	GEMSTAR SYSTEM	Jul 13, 1982	Substantially Equivalent	ELECTRO-NUCLEONICS LABORATORIES, INC.
K820888	8700 CLINICAL CHEM. ANALYZER	May 14, 1982	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K820687	DUPONT AUTOMATIC CLINICAL ANALYZER	Apr 01, 1982	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K820118	ELECTROLYTE ANALYZER ACCESSORY	Feb 04, 1982	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K813160	BECKMAN SYSTEM E4A	Dec 10, 1981	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K813102	POLI-MAK II	Nov 24, 1981	Substantially Equivalent	PM AMERICA, INC.
K811919	KODAK EKTACHEM 400 ANALYZER	Jul 23, 1981	Substantially Equivalent	EASTMAN KODAK COMPANY
K811194	HITACHI 705 AUTOMATIC BLOOD CHEMISTRY	May 27, 1981	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K810549	THERMAL PRINTER PAPER	Apr 08, 1981	Substantially Equivalent	NOBEL SCIENTIFIC INDUSTRIES, INC.
K810596	CENTRIFI CHEM SYSTEM 400 ANALYZER	Mar 17, 1981	Substantially Equivalent	UNION CARBIDE CORP.
K810129	CENTRIFICHEM SYSTEM 500	Feb 02, 1981	Substantially Equivalent	UNION CARBIDE CORP.
K803267	AUTOMATED IMMUOCHEMISTRY SYSTEM	Jan 16, 1981	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K803135	PARALLEL CHEMICAL ANALYZER	Jan 09, 1981	Substantially Equivalent	AMERICAN MONITOR CORP.
K802835	COMPU-CHEM II CHEMISTRY ANALYZER	Dec 11, 1980	Substantially Equivalent	DIAGNOSTIC AIDS, INC.
K802609	CHEMISTRY ANALYZER IMPACT 400	Nov 26, 1980	Substantially Equivalent	GILFORD INSTRUMENT LABORATORIES, INC.
K802320	COULTER DACOS SERUM CHEM. ANALYZER	Oct 31, 1980	Substantially Equivalent	COULTER ELECTRONICS, INC.
K801889	MODEL 203S CLINICAL CHEMISTRY ANALYZER	Sep 26, 1980	Substantially Equivalent	GILFORD INSTRUMENT LABORATORIES, INC.
K800572	KDA MICRO CHEMICAL ANALYZER	Apr 02, 1980	Substantially Equivalent	AMERICAN MONITOR CORP.
K800085	SYSTEM 203 CHEMISTRY ANALYZER	Feb 13, 1980	Substantially Equivalent	GILFORD INSTRUMENT LABORATORIES, INC.
K800053	KODAK EKTACHEM FOUR CHEMISTRY ANALYZER	Jan 23, 1980	Substantially Equivalent	EASTMAN KODAK COMPANY
K792361	SYSTEM 103 CHEMISTRY ANALYZER	Dec 27, 1979	Substantially Equivalent	GILFORD INSTRUMENT LABORATORIES, INC.
K791297	PRISMA	Aug 10, 1979	Substantially Equivalent	LKB INSTRUMENTS, INC.
K791296	CHEMETRICS ANALYZER II	Aug 03, 1979	Substantially Equivalent	CHEMETRICS CORP.
K790072	ANALYZER, IMPACT 200	Feb 22, 1979	Substantially Equivalent	GILFORD INSTRUMENT LABORATORIES, INC.
K782014	ANALYZER ABA-200	Jan 10, 1979	Substantially Equivalent	ABBOTT LABORATORIES
K781528	COULTER ELECTROLYTE ANALYZER SYSTEM	Sep 27, 1978	Substantially Equivalent	COULTER ELECTRONICS, INC.
K781076	CHEMISTRY ANALYZER	Aug 14, 1978	Substantially Equivalent	JOHNS SCIENTIFIC, INC.
K780464	LELECTIVE KINETIC SYSTEM-60	May 03, 1978	Substantially Equivalent	HYCEL, INC.
K780388	ANALYZER, 100, BICHROMATIC, ABBOTT	Mar 22, 1978	Substantially Equivalent	SYVA CO.
K780083	ANALYZER, SELECTIVE, ELECTRONIC	Mar 09, 1978	Substantially Equivalent	JOHNS SCIENTIFIC, INC.
K772344	DATA ACQUISITION & COLLATING SYS.	Jan 31, 1978	Substantially Equivalent	GILFORD INSTRUMENT LABORATORIES, INC.
K772319	ANALYZER, CLINICAL, SYSTEM 3	Jan 12, 1978	Substantially Equivalent	GILFORD INSTRUMENT LABORATORIES, INC.
K771245	MODEL 2/2 ANALYZER	Oct 07, 1977	Substantially Equivalent	EASTMAN KODAK COMPANY
K771345	BICHROMATIC ANALYZER ABA-200	Aug 04, 1977	Substantially Equivalent	ABBOTT LABORATORIES
K770679	CHEMISTRY, COULTER	May 03, 1977	Substantially Equivalent	COULTER ELECTRONICS, INC.
K760642	ANALYZER, PROGRAMMABLE DISCRETE (PDA)	Dec 09, 1976	Substantially Equivalent	ANATRONICS CORP.

FEI Numbers

This FDA classification entry is associated with 180 FEI numbers. Click on an entry to view related FDA registrations.

1000119795: 30 registrations

1000120319: 2 registrations

1000122044: 23 registrations

1000122204: 9 registrations

1000125596: 34 registrations

1000125787: 8 registrations

1000135102: 101 registrations

1000136573: 169 registrations

1000186023: 15 registrations

1000206808: 104 registrations

1000221217: 5 registrations

1000256526: 5 registrations

1000305840: 46 registrations

1000305841: 51 registrations

1000455123: 1 registration

1000611339: 35 registrations

1036223: 5 registrations

1036362: 17 registrations

1181121: 182 registrations

1217183: 82 registrations

1219029: 104 registrations

1219913: 131 registrations

1220972: 44 registrations

1317202: 7 registrations

1415939: 11 registrations

1616487: 87 registrations

1643621: 13 registrations

1717966: 24 registrations

1827821: 149 registrations

1832216: 187 registrations

1931251: 4 registrations

2020726: 75 registrations

2026994: 126 registrations

2050010: 124 registrations

2050012: 131 registrations

2122870: 105 registrations

2182595: 56 registrations

2221819: 65 registrations

2245578: 23 registrations

2250051: 152 registrations

2431530: 77 registrations

2432235: 462 registrations

2517506: 354 registrations

2523553: 4 registrations

2915274: 100 registrations

2915796: 4 registrations

2967: 109 registrations

3000148879: 72 registrations

3000215862: 96 registrations

3000303338: 36 registrations

3000308930: 136 registrations

3001075266: 5 registrations

3001236277: 474 registrations

3001576181: 4 registrations

3001644026: 148 registrations

3002485711: 39 registrations

3002608770: 5 registrations

3002642396: 139 registrations

3002806559: 387 registrations

3002806560: 8 registrations

3002806809: 96 registrations

3002806944: 152 registrations

3002807663: 8 registrations

3002807876: 57 registrations

3002808212: 57 registrations

3002808301: 56 registrations

3002808340: 97 registrations

3002808382: 216 registrations

3002809144: 150 registrations

3002889627: 6 registrations

3002895169: 6 registrations

3003030793: 34 registrations

3003071743: 72 registrations

3003261083: 5 registrations

3003268355: 61 registrations

3003402518: 13 registrations

3003413192: 18 registrations

3003542872: 51 registrations

3003559191: 20 registrations

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3003593973: 38 registrations

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3003741796: 84 registrations

3003795116: 46 registrations

3003917514: 70 registrations

3003992026: 25 registrations

3004102403: 13 registrations

3004145393: 98 registrations

3004185580: 70 registrations

3004378326: 2 registrations

3004434309: 14 registrations

3004438098: 4 registrations

3004445302: 35 registrations

3004493545: 205 registrations

3004529019: 9 registrations

3004973408: 74 registrations

3005094123: 56 registrations

3005333358: 273 registrations

3005342322: 4 registrations

3005509212: 3 registrations

3005529799: 96 registrations

3005643513: 35 registrations

3005655287: 2 registrations

3005748564: 3 registrations

3005748784: 2 registrations

3006198300: 142 registrations

3006677029: 4 registrations

3006716639: 13 registrations

3006897868: 2 registrations

3007019572: 14 registrations

3007111389: 69 registrations

3007118747: 106 registrations

3007135420: 19 registrations

3007208259: 47 registrations

3007262384: 5 registrations

3007361513: 71 registrations

3007500635: 1 registration

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3007662974: 42 registrations

3008237827: 79 registrations

3008244372: 6 registrations

3008344661: 27 registrations

3008425728: 7 registrations

3008494306: 9 registrations

3008517993: 82 registrations

3008853996: 1 registration

3009156722: 110 registrations

3009238284: 95 registrations

3009297077: 9 registrations

3009473156: 6 registrations

3009518015: 59 registrations

3009617712: 165 registrations

3009711478: 55 registrations

3009880320: 2 registrations

3010031137: 8 registrations

3010324880: 12 registrations

3010421384: 35 registrations

3010665957: 6 registrations

3010825766: 5 registrations

3011061417: 8 registrations

3011179004: 2 registrations

3011497847: 12 registrations

3011989923: 99 registrations

3012057020: 1 registration

3012471076: 98 registrations

3012526002: 2 registrations

3012775350: 91 registrations

3012963943: 138 registrations

3013660430: 64 registrations

3014233026: 56 registrations

3014325803: 69 registrations

3014353045: 23 registrations

3014607865: 23 registrations

3014643041: 4 registrations

3014717638: 2 registrations

3014840402: 3 registrations

3015550354: 517 registrations

3015969360: 2 registrations

3016244760: 1 registration

3016438761: 72 registrations

3017019647: 19 registrations

3017098711: 6 registrations

3017098905: 2 registrations

3017121083: 5 registrations

3017548799: 4 registrations

3018771894: 23 registrations

3020978007: 22 registrations

3021394862: 2 registrations

3022178699: 180 registrations

3023162659: 45 registrations

3023268435: 2 registrations

3024082778: 34 registrations

3027318375: 7 registrations

3027977508: 4 registrations

3029973107: 7 registrations

3030234142: 4 registrations

3030493719: 1 registration

3033967997: 3 registrations

3035708936: 20 registrations

3037000637: 103 registrations