Product Code: JLW FDA class 2 21 CFR 862.1690

Radioimmunoassay, Thyroid-Stimulating Hormone

Clinical Chemistry

This device is a radioimmunoassay system used to measure thyroid-stimulating hormone (TSH) in patient serum, used in the diagnosis and monitoring of thyroid disorders including hypothyroidism, hyperthyroidism, and pituitary dysfunction affecting thyroid regulation. It is classified as FDA Class 2, requiring 510(k) premarket notification, under 21 CFR 862.1690, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

242

FEI Numbers

Registration Numbers

Unique Applicants

137

Years Active

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Basic Information

Product Code: JLW
Device Class: FDA class 2
Regulation Number: 862.1690
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 242 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251543	Atellica® IM TSH3-Ultra II (TSH3ULII)	Feb 06, 2026	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K243570	Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)	Apr 25, 2025	Substantially Equivalent	Siemens Healthcare Diagnostics
K234091	Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0	Jul 22, 2024	Substantially Equivalent	Genalyte, Inc.
K233050	ADVIA Centaur® TSH3-Ultra II (TSH3ULII)	Apr 04, 2024	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K222116	Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)	Jul 13, 2023	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K221225	Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer	Nov 10, 2022	Substantially Equivalent	Beckman Coulter, Inc.
K190773	Elecsys TSH	Apr 16, 2019	Substantially Equivalent	Roche Diagnostics
K170232	AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer	Oct 13, 2017	Substantially Equivalent	Boditech Med, Inc.
K171103	Lumipulse G TSH-III Immunoreaction Cartridges	Jul 28, 2017	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K162698	MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer	Jul 14, 2017	Substantially Equivalent	Shenzhen New Industries Biomedical Engineering Co., Ltd.
K162606	Elecsys TSH assay, cobas e 801 Immunoassay analyzer	Jan 23, 2017	Substantially Equivalent	Roche Diagnostics
K160541	Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control	Oct 21, 2016	Substantially Equivalent	Sysmex America, Inc.
K153651	Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems	Aug 18, 2016	Substantially Equivalent	Beckman Coulter, Inc.
K160647	IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4	May 31, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K151792	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System	Nov 20, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K150403	ADVIA Centaur TSH3-Ultra	May 01, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K141999	ADVIA CENTAUR TSH	Apr 22, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K131928	FREND TSH (REAGENT CARTRIDGE)	Mar 14, 2014	Substantially Equivalent	Nanoentek USA, Inc.
K130469	LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3	Apr 05, 2013	Substantially Equivalent	DiaSorin, Inc.
K110761	MICT TSH	Mar 09, 2012	Substantially Equivalent	Magnabiosciences, LLC
K101390	FASTPACK TSH IMMUNOASSAY	Aug 13, 2010	Substantially Equivalent	Qualigen, Inc.
K090846	GSP INSTRUMENT AND GSP NEONATAL HTSH KIT	Sep 03, 2009	Substantially Equivalent	Perkinelmer, Inc.
K083844	ADVIA CENTAUR TSH3-ULTRA METHOD	May 08, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K083173	VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM	Dec 22, 2008	Substantially Equivalent	Ortho-Clinical Diagnostics
K081543	VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM	Oct 23, 2008	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K081074	DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691	May 23, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K072458	GBI TSH NEONATAL SCREENING KIT	Apr 10, 2008	Substantially Equivalent	Golden Bridge International, Inc.
K063437	ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300	Apr 04, 2008	Substantially Equivalent	Monobind, Inc.
K062581	OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM	Nov 29, 2006	Substantially Equivalent	Olympus America, Inc.
K060090	DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE	Feb 27, 2006	Substantially Equivalent	Dade Behring, Inc.
K052301	FASTPACK TSH IMMUNOASSAY	Jan 04, 2006	Substantially Equivalent	Qualigen, Inc.
K042281	MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY	Sep 16, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K041014	TSH-CTK-3 IRMA	Jul 14, 2004	Substantially Equivalent	DiaSorin, Inc.
K030912	THYRO TEST	Jul 25, 2003	Substantially Equivalent	Thryotec
K023093	ACCESS HYPERSENSITIVE HTSH ASSAY	Nov 25, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K013420	CHEMWELL, ALSO KNOWN AS PROJECT 2900	Jul 19, 2002	Substantially Equivalent	Awareness Technology, Inc.
K011527	PRAXSYS RELIA TSH TEST	Aug 07, 2001	Substantially Equivalent	Praxsys Biosystems, Inc.
K011525	SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)	Jul 16, 2001	Substantially Equivalent	Biosafe Laboratories, Inc.
K003752	BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)	Mar 23, 2001	Substantially Equivalent	Biosafe Laboratories, Inc.
K001455	ACCUWELL TSH, MODEL KAW-TSH-960	Nov 02, 2000	Substantially Equivalent	Neometrics, Inc.
K001606	REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)	Oct 05, 2000	Substantially Equivalent	Repromedix Corp.
K991146	TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001	Jun 22, 1999	Substantially Equivalent	Biocheck, Inc.
K990993	BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003	Jun 22, 1999	Substantially Equivalent	Biocheck, Inc.
K990658	THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY	Jun 02, 1999	Substantially Equivalent	Little Nell Labs, Inc.
K983442	ABBOTT ARCHITECT TSH	Nov 20, 1998	Substantially Equivalent	Abbott Laboratories
K981312	3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	Jun 05, 1998	Substantially Equivalent	Bayer Corp.
K981060	ABBOTT AXSYM 3RD GENERATION TSH ASSAY	Apr 29, 1998	Substantially Equivalent	Abbott Laboratories
K980574	AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0	Mar 24, 1998	Substantially Equivalent	Alfa Biotech (Uk) , Ltd.
K973276	AUTODELFIA NEONATAL HTSH L KIT (B077-112)	Nov 20, 1997	Substantially Equivalent	Eg &G Wallac
K972586	AIA-PACK TSH 3RD-GEN ASSAY	Aug 29, 1997	Substantially Equivalent	Tosoh Medics, Inc.
K971780	THYROTROPIN(TSH) ELISA	Jun 24, 1997	Substantially Equivalent	Monobind
K970393	THYROID STIMULATING HORMONE METHOD	Mar 03, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K964558	VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)	Dec 16, 1996	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K961566	BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS	Nov 18, 1996	Substantially Equivalent	Biocircuits Corp.
K962464	SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)	Oct 08, 1996	Substantially Equivalent	Scantibodies Laboratory, Inc.
K962216	TSH (MICROWELL) ELISA	Sep 19, 1996	Substantially Equivalent	Biomerica, Inc.
K961629	THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST	Sep 11, 1996	Substantially Equivalent	Teco Diagnostics
K961491	ELECSYS TSH ASSAY	Jul 22, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K961650	NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT	Jul 16, 1996	Substantially Equivalent	Nichols Institute Diagnostics
K960195	THYROCHEK ONE-STEP RAPID TSH ASSAY	Apr 15, 1996	Substantially Equivalent	Franklin Diagnostics, Inc.
K954825	ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	Nov 21, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K952211	AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)	Jul 14, 1995	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K952148	AXSYM ULTRASENSITIVE HTSH II	Jun 29, 1995	Substantially Equivalent	Abbott Laboratories
K951796	CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY	Jun 13, 1995	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K950921	CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY	May 02, 1995	Substantially Equivalent	Nichols Institute Diagnostics
K943195	COAT-A-COUNT NEONATAL TSH IRMA	Mar 13, 1995	Substantially Equivalent	Diagnostic Products Corp.
K942658	NEOSCREEN ELISA TSH	Feb 24, 1995	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K942661	AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT	Jan 17, 1995	Substantially Equivalent	Sealite Sciences, Inc.
K940006	IMMULITE THIRD GENERATION (MODIFICATION)	Dec 19, 1994	Substantially Equivalent	Diagnostic Products Corp.
K935399	RADIAS NEONATAL TSH ENZYME IMMUNOASSAY	Dec 19, 1994	Substantially Equivalent	Bio-Rad
K933212	IMMULITE RAPID TSH	Dec 19, 1994	Substantially Equivalent	Diagnostic Products Corp.
K941146	DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM	Oct 03, 1994	Substantially Equivalent	Dupont Medical Products
K935049	ELEGANCE NEONATAL TSH ELISA	Oct 03, 1994	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K942566	IMX ULTRASENSISTIVE HTSH II	Aug 16, 1994	Substantially Equivalent	Abbott Laboratories
K934410	AXSYM ULTRASENSITIVE HTSH	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K935119	RADIAS 3RD GENERATION TSH IMMUNOASSAY	Apr 06, 1994	Substantially Equivalent	Bio-Rad
K930776	COBAS CORE TSH EIA	Dec 03, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K930006	AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT	Sep 09, 1993	Substantially Equivalent	Bio-Chem Laboratory Systems, Inc.
K930050	SIA THYROID STIMULATING HORMONE ELISA KIT	Aug 19, 1993	Substantially Equivalent	Sigma Chemical Co.
K931061	RADIAS TSH ENZYME IMMUNOASSAY	Jun 16, 1993	Substantially Equivalent	Bio-Rad
K923532	NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY	Mar 12, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K925637	ACCESS HTSH ASSAY	Mar 01, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K925132	BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE	Dec 28, 1992	Substantially Equivalent	Becton Dickinson Advanced Diagnostics
K923401	DELFIA HTSH ULTRA KIT	Nov 30, 1992	Substantially Equivalent	Wallac OY
K922701	DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD	Sep 09, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K922138	VISTA ULTRASENSITIVE HTSH ASSAY	Jul 21, 1992	Substantially Equivalent	Syva Co.
K922736	KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA	Jul 10, 1992	Substantially Equivalent	Eastman Kodak Company
K921958	ELISA TUBE TSH TEST	Jul 02, 1992	Substantially Equivalent	Bio Clinic Co.
K921700	TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093	Jun 29, 1992	Substantially Equivalent	Medix Biotech, Inc.
K921816	VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY	Jun 18, 1992	Substantially Equivalent	Biomerieux Vitek, Inc.
K920856	VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS	Mar 26, 1992	Substantially Equivalent	Hycor Biomedical, Inc.
K920442	IMMUCHEM TSH-MW ELISA	Mar 18, 1992	Substantially Equivalent	Icn Biomedicals, Inc.
K915195	ENZYMUN-TEST TSH	Feb 14, 1992	Substantially Equivalent	Boehringer Mannheim Corp.
K914756	ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT	Jan 15, 1992	Substantially Equivalent	Medix Biotech, Inc.
K913963	IMMUCHEM NEONATAL TSH-MP ELISA	Dec 13, 1991	Substantially Equivalent	Icn Biomedicals, Inc.
K912852	STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO	Sep 27, 1991	Substantially Equivalent	Baxter Healthcare Corp
K912583	MAGIC LITE TSH (HS) IMMUNOASSAY	Aug 12, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K912324	NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY	Jun 20, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K912241	STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY	Jun 20, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910837	SRI TSH IMMUNENZYMETRIC ASSAY	May 24, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K910981	CIBA CORNING ACS TSH IMMUNOASSAY	Apr 30, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K910411	MICROZYME TSH ENZYME IMMUNOASSAY KIT	Apr 03, 1991	Substantially Equivalent	Immunotech Corp.
K910256	ECLIPSE ICA TSH	Feb 22, 1991	Substantially Equivalent	Biotope, Inc.
K905710	PHARMACIA DELFIA NEONATAL HTSH KIT	Feb 21, 1991	Substantially Equivalent	Pharmacia, Inc.
K905769	IMMULITE HS-TSH	Jan 31, 1991	Substantially Equivalent	Cirrus Diagnostics, Inc.
K905099	ELEGANCE TSH ELISA	Dec 18, 1990	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K904666	AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008	Nov 02, 1990	Substantially Equivalent	Amersham Corp.
K903725	EZ-BEAD TSH ENZYME IMMUNOASSAY KIT	Oct 26, 1990	Substantially Equivalent	Immunotech Corp.
K903391	ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM	Oct 12, 1990	Substantially Equivalent	Nichols Institute
K903311	NOVAPATH TSH ENZYME IMMUNOASSAY	Sep 07, 1990	Substantially Equivalent	Bio-Rad
K902753	IMX ULTRASENTITIVE HTSH	Jul 10, 1990	Substantially Equivalent	Abbott Mfg., Inc.
K902333	OPUS TSH TEST SYSTEM	Jul 05, 1990	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K900277	ENZYMUN TEST(R) TSH-S	Apr 11, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K897138	AFFINITY(TM) HTSH(TM)	Mar 09, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K896867	THYROID STIMULATING HORMONE-EIA-XT	Feb 23, 1990	Substantially Equivalent	In Vitro Diagnostics, Inc.
K900014	MILENIA (TM) TSH	Jan 19, 1990	Substantially Equivalent	Diagnostic Products Corp.
K895396	CYBERFLUOR FIAGEN TSH	Oct 31, 1989	Substantially Equivalent	Cyberfluor, Inc.
K890802	COTUBE(TM) TSH IRMA	Mar 28, 1989	Substantially Equivalent	Bio-Rad
K890579	TSH MICROASSAY	Mar 16, 1989	Substantially Equivalent	Diamedix Corp.
K885157	VENTREX COATED TUBE HIGH SENSITIVITY TSH	Feb 10, 1989	Substantially Equivalent	Ventrex Laboratories, Inc.
K883742	MODIFIED TSH IRMA KIT	Jan 03, 1989	Substantially Equivalent	Pacific Biotech, Inc.
K883726	THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL	Dec 15, 1988	Substantially Equivalent	Immuchem Corp.
K881627	DELFIA(TM) NEONATAL HTSH KIT	Oct 03, 1988	Substantially Equivalent	Pharmacia, Inc.
K882907	AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT	Sep 22, 1988	Substantially Equivalent	Amersham Corp.
K883342	VENTREX COATED TUBE TSH	Sep 13, 1988	Substantially Equivalent	Ventrex Laboratories, Inc.
K881381	REAGENTS FOR TSH ASSAY	Jul 21, 1988	Substantially Equivalent	Sclavo, Inc.
K881443	LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY	May 27, 1988	Substantially Equivalent	London Diagnostics, Inc.
K880086	ABBOTT IMX HTSH	Apr 05, 1988	Substantially Equivalent	Abbott Laboratories
K874622	FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301	Dec 18, 1987	Substantially Equivalent	Cyberfluor, Inc.
K874061	TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093	Nov 03, 1987	Substantially Equivalent	Medix Biotech, Inc.
K873303	BINAX L.S. TSH IRMA TEST KIT	Oct 02, 1987	Substantially Equivalent	Binax, Inc.
K872897	TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.	Jul 31, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K872305	IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX	Jul 01, 1987	Substantially Equivalent	Diagnostic Products Corp.
K871505	AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT	May 26, 1987	Substantially Equivalent	Micromedic Systems
K870904	MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT	May 26, 1987	Substantially Equivalent	Micromedic Systems
K871644	DELFIA (TM) HTSH KIT	May 12, 1987	Substantially Equivalent	Lkb Instruments, Inc.
K870245	AUTOPAK TSH MONOCLONAL IRMA KIT	Apr 01, 1987	Substantially Equivalent	Micromedic Systems
K870244	IQ TSH IMMUNOASSAY	Apr 01, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K870320	DACOMED PENILE PROSTHESIS SIZER	Mar 17, 1987	Substantially Equivalent	Dacomed Corp.
K865071	THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT	Mar 13, 1987	Substantially Equivalent	Immuchem Corp.
K865081	AFFINITY(TM) HTSH IMMUNIT(TM)	Mar 12, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K864839	TSH MAB IRMA	Feb 04, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K864659	BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH	Feb 04, 1987	Substantially Equivalent	Bio Mega Diagnostic, Inc.
K864677	TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP	Jan 07, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K864133	DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT	Dec 18, 1986	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K864134	DSL-4800 ACTIVE TM TSH EIA SYSTEM	Dec 16, 1986	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K864079	UBI MAGIWEL(TM) TSH QUANTITATIVE	Dec 16, 1986	Substantially Equivalent	United Biotech, Inc.
K863859	TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM	Nov 21, 1986	Substantially Equivalent	Hybritech, Inc.
K862407	CIBA CORNING MAGIC LITE TSH IMMUNOASSAY	Aug 29, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K862428	STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY	Aug 19, 1986	Substantially Equivalent	American Dade
K860813	MICROMEDIC HTSH MONOCLONAL IRMA KIT	Jul 14, 1986	Substantially Equivalent	Micromedic Systems
K861918	V-TREND EIA TSH	Jul 02, 1986	Substantially Equivalent	V-Tech, Inc.
K862249	TSH IRMA KIT	Jun 27, 1986	Substantially Equivalent	Pacific Biotech, Inc.
K861573	TERUMO SENSIBEAD EIA TSH KIT	Jun 19, 1986	Substantially Equivalent	Terumo Medical Corp.
K861920	SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.	Jun 16, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K860824	TSHK-NN RIA KIT	Apr 28, 1986	Substantially Equivalent	Cis-Us, Inc.
K860288	ECHOCLONAL HTSH IRMA	Apr 11, 1986	Substantially Equivalent	Bio-Rad
K860054	TSH-IRMA COAT-A-COUNT KIT	Mar 17, 1986	Substantially Equivalent	Diagnostic Products Corp.
K854379	MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT	Jan 07, 1986	Substantially Equivalent	Bioclinical Systems, Inc.
K854087	NML TSH IRMA	Oct 25, 1985	Substantially Equivalent	Organon Teknika Corp.
K853977	BETA-TSH-IRMA	Oct 22, 1985	Substantially Equivalent	Leeco Diagnostics, Inc.
K853717	ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM	Oct 02, 1985	Substantially Equivalent	Nichols Institute Diagnostics
K852438	NML TSH IRMA	Jul 12, 1985	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K852224	LEE-BEAD TSH(EIA)	Jul 09, 1985	Substantially Equivalent	Lecco Diagnostics, Inc.
K851329	MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA	Jun 13, 1985	Substantially Equivalent	Corning Medical & Scientific
K851980	ENDAB TSH	May 31, 1985	Substantially Equivalent	Immunotech Corp.
K851120	DELFIA HTSH KIT	May 31, 1985	Substantially Equivalent	Lkb Instruments, Inc.
K851148	TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE	Apr 29, 1985	Substantially Equivalent	Euro-Diagnostics BV
K844583	TSH-STAT	Mar 05, 1985	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K850376	TERUMO SENSIBEAD EIA TSH KIT	Mar 04, 1985	Substantially Equivalent	Terumo Medical Corp.
K843540	ABBOTT HTSH EIA DIAGNOSTIC KIT	Nov 02, 1984	Substantially Equivalent	Abbott Laboratories
K843395	ENCORE TSH REAGENT	Oct 11, 1984	Substantially Equivalent	Hybritech, Inc.
K843545	TSH QUIK RIA KIT	Oct 02, 1984	Substantially Equivalent	Pacific Biotech, Inc.
K843281	ACCUSCREEN TSH	Sep 26, 1984	Substantially Equivalent	Neometrics, Inc.
K842593	SUCROSEP THYROID STIMULATING HORMONE	Sep 12, 1984	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K842948	AMERLEX-M TSH RIA	Sep 04, 1984	Substantially Equivalent	Amersham Corp.
K841606	BLOOD SPOT NEONATAL TSH RADIOIMMUNO	May 22, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K840088	BIODEX ACT-O-KIT TSH-RIA-	May 07, 1984	Substantially Equivalent	Biodan Medical Systems, Ltd.
K833193	RADIOIMMUNOASSAY, THYROID STIMU. HORMONE	Feb 04, 1984	Substantially Equivalent	Biosan Laboratories, Inc.
K833713	SERUM THYROTROPIN ASSAY KIT, TIPSEP-	Dec 29, 1983	Substantially Equivalent	Nuclear Diagnostics, Inc.
K832813	TANDEM-E THYROID STIMULATING HORMONE KIT	Oct 31, 1983	Substantially Equivalent	Hybritech, Inc.
K832823	ENZYMUNE-TEST TSH	Oct 14, 1983	Substantially Equivalent	Icl Scientific
K831972	EPSILON TSH TEST KIT	Sep 20, 1983	Substantially Equivalent	Beckman Instruments, Inc.
K832499	PHASE II TSH KIT	Sep 12, 1983	Substantially Equivalent	Medical & Scientific Designs, Inc.
K832462	AUTOPAK NEONATAL TSH RIA KIT	Sep 12, 1983	Substantially Equivalent	Micromedic Systems
K832313	MAGIC TSH 125I RADIOIMMUNOASSAY	Sep 01, 1983	Substantially Equivalent	Corning Medical & Scientific
K830928	VENTREX ENZYME TSH KIT	Apr 28, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K830036	NEONATAL NTSH RADIOIMMUNOASSAY SYS	Jan 28, 1983	Substantially Equivalent	Corning Medical & Scientific
K823688	DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO	Jan 05, 1983	Substantially Equivalent	Corning Medical & Scientific
K822935	THYROID STIMULATING HORMONE	Nov 01, 1982	Substantially Equivalent	Pcl-Ria, Inc.
K822827	HISH EIA DIAGNOSTIC KIT	Oct 27, 1982	Substantially Equivalent	Abbott Laboratories
K822705	TAMDEM-R THYROID STIMULATING HORMONE KIT	Oct 13, 1982	Substantially Equivalent	Hybritech, Inc.
K822291	QUANTIMUNE HTSH IRMA	Aug 27, 1982	Substantially Equivalent	Bio-Rad
K821620	(125I) HTSH RADIOIMMUNOASSAY KIT	Jun 14, 1982	Substantially Equivalent	Yang Laboratories, Inc.
K821174	TSH-SQUIBB RADIOIMMUNOASSAY KIT	May 14, 1982	Substantially Equivalent	Squibb & Sons, Inc.
K820089	TSH (RIA) KIT	Jan 28, 1982	Substantially Equivalent	Immuno Assay Corp.
K813645	MICROMEDIC HTSH RIA KIT	Jan 22, 1982	Substantially Equivalent	Micromedic Systems
K813525	IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY	Dec 31, 1981	Substantially Equivalent	Micromedic Systems
K813392	RADIOIMMUNOASSAY FOR HUMAN THYROID	Dec 22, 1981	Substantially Equivalent	Leeco Diagnostics, Inc.
K812136	AMERLEX TSH RIA KIT	Aug 13, 1981	Substantially Equivalent	Amersham Corp.
K811558	TSH-P.E.G.	Jun 18, 1981	Substantially Equivalent	Nuclear Diagnostics, Inc.
K811431	TECHNICON STAR SYSTEM	Jun 09, 1981	Substantially Equivalent	Technicon Instruments Corp.
K810948	RADIOIMMUNOASSAY THYROID STIM. HORM. KIT	Apr 17, 1981	Substantially Equivalent	Endocrine-Metabolic Center
K810213	DAC-CEL TSH	Feb 10, 1981	Substantially Equivalent	Burroughs Wellcome Co.
K802467	TSH RADIOIMMUNOASSAY KIT	Oct 31, 1980	Substantially Equivalent	American Diagnostic Corp.
K801691	TSH RIASSAY	Aug 27, 1980	Substantially Equivalent	Ria Diagnostics
K801560	VENTREX/SEP TSH TEST SET	Aug 13, 1980	Substantially Equivalent	Ventrex Laboratories, Inc.
K800798	HUMAN THYROID STIM. HORMONE/ARIA II	Apr 24, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K792562	IMMUNOSTAT TSH TEST	Jan 16, 1980	Substantially Equivalent	Meloy Laboratories, Inc.
K792443	TSH RADIOIMMUNOASSAY	Dec 27, 1979	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K792154	THYROID STIMULATING HORMONE	Nov 13, 1979	Substantially Equivalent	Radioimmunoassay, Inc.
K791747	HTSH NEONATE RIA DIAGNOSTIC KIT	Nov 13, 1979	Substantially Equivalent	Abbott Laboratories
K791855	CENTRIA TSH RIA	Oct 17, 1979	Substantially Equivalent	Union Carbide Corp.
K791301	ORTHO TSH RIA KIT	Sep 24, 1979	Substantially Equivalent	Ortho Diagnostics, Inc.
K791217	TSH RIA KIT	Sep 04, 1979	Substantially Equivalent	Antibodies, Inc.
K791065	IMMUNOSPOT TSH TEST	Jul 30, 1979	Substantially Equivalent	Meloy Laboratories, Inc.
K790260	NTSH AUTOPAK TEST DELIVERY SYSTEM	Mar 21, 1979	Substantially Equivalent	Micromedic Systems
K781953	RIA KIT, IMMO PHASE	Feb 01, 1979	Substantially Equivalent	Corning Medical & Scientific
K781409	IMMO PHASE, THYROID HORMONE	Sep 27, 1978	Substantially Equivalent	Corning Medical & Scientific
K781296	THYRO-SHURE	Aug 31, 1978	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K781170	QUANTIMUNE HTSH IRMA HUMAN THYROID	Aug 14, 1978	Substantially Equivalent	Bio-Rad
K781150	RIA TSH IN HUMAN SERUM OR PLASMA	Jul 27, 1978	Substantially Equivalent	Diagnostic Corp. of America
K780726	TSH RIA KIT	Jun 13, 1978	Substantially Equivalent	Amersham Corp.
K780428	ROCHE TSH RIA	Mar 30, 1978	Substantially Equivalent	Hoffmann-La Roche, Inc.
K780059	RABBIT ANTIBODY/THYROID STIMUL. HORMONE	Feb 13, 1978	Substantially Equivalent	Pcl-Ria, Inc.
K780015	THYROID STIMULATING HORMONE	Feb 07, 1978	Substantially Equivalent	Pcl-Ria, Inc.
K772192	NEONATAL TSH RIA KIT (125I)	Jan 12, 1978	Substantially Equivalent	Diagnostic Products Corp.
K772109	IN VITRO HUMAN TSH RIA TEST	Dec 06, 1977	Substantially Equivalent	Clinical Assays, Inc.
K771767	SERALUTE TSH (RIA)	Oct 25, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K771378	NEO TSH-RIA KIT	Oct 18, 1977	Substantially Equivalent	Nuclear Medical Systems, Inc.
K771234	TSH RIA REAGENT SET	Oct 18, 1977	Substantially Equivalent	G.D. Searle and Co.
K771590	THYROID STIMULATING HORMONE	Sep 15, 1977	Substantially Equivalent	New England Nuclear
K771377	THYRODOT-4, THYRODOT-SH	Sep 02, 1977	Substantially Equivalent	Medcom Diagnostics, Inc.
K771222	TSH RIA TEST SYSTEM	Aug 04, 1977	Substantially Equivalent	Monobind
K771235	HTSH RIA HUMAN THYROID HORMONE RIA	Aug 03, 1977	Substantially Equivalent	Abbott Laboratories
K770915	CLASP RIA KIT, HTSH	Jun 14, 1977	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K770892	TSH RADIOIMMUNOASSAY	Jun 14, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K770604	RIA-DAC TM HTSH KIH	Apr 06, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K760255	TEST SYSTEM, THYROID STIM. HORMONE ASSAY	Nov 19, 1976	Substantially Equivalent	Corning Medical & Scientific
K760801	TSH RIA KIT	Nov 01, 1976	Substantially Equivalent	Diagnostic Products Corp.
K760044	KIT, RIA, HUMAN THYROID HORMONE	Jul 26, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760132	TEST, RIA, TSH QUANTIMUNE	Jul 20, 1976	Substantially Equivalent	Bio-Rad