Panels › Clinical Chemistry › Product code JLW · Class 2
Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation 862.1690
1510(k)s in 12 months (242 all time)
1recalls in 12 months (46 all time)
44recalls that name a 510(k)
Top companies in JLW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 1997 | K971780 | THYROTROPIN(TSH) ELISA Monobind | JLW |
| Mar 3, 1997 | K970393 | THYROID STIMULATING HORMONE METHOD Dade Chemistry Systems, Inc. | JLW |
| Dec 16, 1996 | K964558 | VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) Johnson & Johnson Clinical Diagnostics, Inc. | JLW |
| Nov 18, 1996 | K961566 | BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS Biocircuits Corp. | JLW |
| Oct 8, 1996 | K962464 | SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) Scantibodies Laboratory, Inc. | JLW |
| Sep 19, 1996 | K962216 | TSH (MICROWELL) ELISA Biomerica, Inc. | JLW |
| Sep 11, 1996 | K961629 | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST Teco Diagnostics | JLW |
| Jul 22, 1996 | K961491 | ELECSYS TSH ASSAY Boehringer Mannheim Corp. | JLW |
| Jul 16, 1996 | K961650 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT Nichols Institute Diagnostics | JLW |
| Apr 15, 1996 | K960195 | THYROCHEK ONE-STEP RAPID TSH ASSAY Franklin Diagnostics, Inc. | JLW |
| Nov 21, 1995 | K954825 | ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Bio-Rad Laboratories, Inc. | JLW |
| Jul 14, 1995 | K952211 | AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) Johnson & Johnson Clinical Diagnostics, Inc. | JLW |
| Jun 29, 1995 | K952148 | AXSYM ULTRASENSITIVE HTSH II Abbott Laboratories | JLW |
| Jun 13, 1995 | K951796 | CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY Ciba Corning Diagnostics Corp. | JLW |
| May 2, 1995 | K950921 | CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY Nichols Institute Diagnostics | JLW |
| Mar 13, 1995 | K943195 | COAT-A-COUNT NEONATAL TSH IRMA Diagnostic Products Corp. | JLW |
| Feb 24, 1995 | K942658 | NEOSCREEN ELISA TSH Pantex, Div. Bio-Analysis, Inc. | JLW |
| Jan 17, 1995 | K942661 | AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT Sealite Sciences, Inc. | JLW |
| Dec 19, 1994 | K940006 | IMMULITE THIRD GENERATION (MODIFICATION) Diagnostic Products Corp. | JLW |
| Dec 19, 1994 | K935399 | RADIAS NEONATAL TSH ENZYME IMMUNOASSAY Bio-Rad | JLW |
| Dec 19, 1994 | K933212 | IMMULITE RAPID TSH Diagnostic Products Corp. | JLW |
| Oct 3, 1994 | K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM Dupont Medical Products | JLW |
| Oct 3, 1994 | K935049 | ELEGANCE NEONATAL TSH ELISA Bioclone Australia Pty , Ltd. | JLW |
| Aug 16, 1994 | K942566 | IMX ULTRASENSISTIVE HTSH II Abbott Laboratories | JLW |
| Jun 21, 1994 | K934410 | AXSYM ULTRASENSITIVE HTSH Abbott Laboratories | JLW |
| Apr 6, 1994 | K935119 | RADIAS 3RD GENERATION TSH IMMUNOASSAY Bio-Rad | JLW |
| Dec 3, 1993 | K930776 | COBAS CORE TSH EIA Roche Diagnostic Systems, Inc. | JLW |
| Sep 9, 1993 | K930006 | AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT Bio-Chem Laboratory Systems, Inc. | JLW |
| Aug 19, 1993 | K930050 | SIA THYROID STIMULATING HORMONE ELISA KIT Sigma Chemical Co. | JLW |
| Jun 16, 1993 | K931061 | RADIAS TSH ENZYME IMMUNOASSAY Bio-Rad | JLW |
| Mar 12, 1993 | K923532 | NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY Solarcare Technologies Corp,Inc. | JLW |
| Mar 1, 1993 | K925637 | ACCESS HTSH ASSAY Bio-Rad Laboratories, Inc. | JLW |
| Dec 28, 1992 | K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE Becton Dickinson Advanced Diagnostics | JLW |
| Nov 30, 1992 | K923401 | DELFIA HTSH ULTRA KIT Wallac OY, FI | JLW |
| Sep 9, 1992 | K922701 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD E.I. Dupont DE Nemours & Co., Inc. | JLW |
| Jul 21, 1992 | K922138 | VISTA ULTRASENSITIVE HTSH ASSAY Syva Co. | JLW |
| Jul 10, 1992 | K922736 | KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA Eastman Kodak Company | JLW |
| Jul 2, 1992 | K921958 | ELISA TUBE TSH TEST Bio Clinic Co. | JLW |
| Jun 29, 1992 | K921700 | TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 Medix Biotech, Inc. | JLW |
| Jun 18, 1992 | K921816 | VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY Biomerieux Vitek, Inc. | JLW |
| Mar 26, 1992 | K920856 | VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS Hycor Biomedical, Inc. | JLW |
| Mar 18, 1992 | K920442 | IMMUCHEM TSH-MW ELISA Icn Biomedicals, Inc. | JLW |
| Feb 14, 1992 | K915195 | ENZYMUN-TEST TSH Boehringer Mannheim Corp. | JLW |
| Jan 15, 1992 | K914756 | ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT Medix Biotech, Inc. | JLW |
| Dec 13, 1991 | K913963 | IMMUCHEM NEONATAL TSH-MP ELISA Icn Biomedicals, Inc. | JLW |
| Sep 27, 1991 | K912852 | STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO Baxter Healthcare Corp | JLW |
| Aug 12, 1991 | K912583 | MAGIC LITE TSH (HS) IMMUNOASSAY Ciba Corning Diagnostics Corp. | JLW |
| Jun 20, 1991 | K912324 | NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | JLW |
| Jun 20, 1991 | K912241 | STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY Baxter Healthcare Corp | JLW |
| May 24, 1991 | K910837 | SRI TSH IMMUNENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | JLW |
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