Panels › Clinical Chemistry › Product code CDP · Class 2
Radioimmunoassay, Total Triiodothyronine
Regulation 862.1710
0510(k)s in 12 months (144 all time)
0recalls in 12 months (20 all time)
13recalls that name a 510(k)
Top companies in CDP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 5, 2000 | K001607 | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) Repromedix Corp. | CDP |
| Jun 18, 1999 | K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 Chiron Diagnostics Corp. | CDP |
| Jun 2, 1999 | K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 Biocheck, Inc. | CDP |
| May 11, 1999 | K991252 | AIA-PACK FT3 ASSAY Tosoh Medics, Inc. | CDP |
| Dec 22, 1998 | K981824 | OPTICOAT T3 EIA KIT Biotecx Laboratories, Inc. | CDP |
| Nov 20, 1998 | K983439 | ABBOTT ARCHITECT FREE T3 Abbott Laboratories | CDP |
| Nov 20, 1998 | K983434 | ABBOTT ARCHITECT TOTAL T3 Abbott Laboratories | CDP |
| Feb 2, 1998 | K974027 | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK Alfa Biotech (Uk) , Ltd., GB | CDP |
| Jan 2, 1998 | K974634 | IMMULITE FREE T3 Diagnostic Products Corp. | CDP |
| Oct 31, 1997 | K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. | CDP |
| Jun 16, 1997 | K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA Monobind | CDP |
| May 22, 1997 | K971270 | DSL ACTIVE T3 EIA Diagnostic Systems Laboratories, Inc. | CDP |
| Mar 11, 1997 | K965058 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT Nichols Institute Diagnostics | CDP |
| Jan 30, 1997 | K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) Johnson & Johnson Clinical Diagnostics, Inc. | CDP |
| Dec 16, 1996 | K963127 | ELECSYS FT3 Boehringer Mannheim Corp. | CDP |
| Nov 29, 1996 | K962760 | ENZYMUN-TEST FT3 Boehringer Mannheim Corp. | CDP |
| Nov 27, 1996 | K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) Johnson & Johnson Clinical Diagnostics, Inc. | CDP |
| Nov 8, 1996 | K963687 | AIA-PACK FT3 ASSAY Tosoh Medics, Inc. | CDP |
| Oct 30, 1996 | K963833 | IMX FREE TRIIODOTHYRONINE (FREE T3) Abbott Laboratories | CDP |
| Oct 30, 1996 | K963827 | AXSYM FREE TRIIODOTHYRONINE (FREE T3) Abbott Laboratories | CDP |
| Aug 15, 1996 | K962508 | ELECSYS T3 Boehringer Mannheim Corp. | CDP |
| Jul 12, 1996 | K962355 | FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | CDP |
| May 30, 1996 | K961236 | UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE United Biotech, Inc. | CDP |
| Mar 29, 1996 | K960913 | ACCESS FREE T3 ASSAY Bio-Rad Laboratories, Inc. | CDP |
| Mar 19, 1996 | K960412 | T-3 MICROWELL EIA MODEL 7013 Biomerica, Inc. | CDP |
| Mar 6, 1996 | K960550 | ACTIVE T3 RIA Diagnostic Systems Laboratories, Inc. | CDP |
| Jan 24, 1996 | K955435 | ACCESS TOTAL T3 ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc. | CDP |
| Jan 24, 1996 | K952557 | TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS Sigma Diagnostics, Inc. | CDP |
| Aug 24, 1995 | K953160 | OPUS T3 Behring Diagnostics, Inc. | CDP |
| Dec 9, 1994 | K944808 | IMX T3 ASSAY Organon Teknika Corp. | CDP |
| Sep 7, 1994 | K940833 | ACCESS(R) TOTAL T3 Bio-Rad Laboratories, Inc. | CDP |
| Jul 14, 1994 | K936229 | AIA-PACK TT3 ASSAY Tosoh Medics, Inc. | CDP |
| Jun 21, 1994 | K934517 | AXSYM TOTAL T3 Abbott Laboratories | CDP |
| Mar 22, 1994 | K934764 | VIDAS T3 ASSAY Biomerieux Vitek, Inc. | CDP |
| Dec 3, 1993 | K932747 | CIBA CORNING ACS FREE T3 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CDP |
| Dec 3, 1993 | K932608 | COBAS(R) CORE T3 EIA Roche Diagnostic Systems, Inc. | CDP |
| Sep 8, 1993 | K931600 | CHEMILUMINESCENCE FREE T3 IMMUNOASSAY Nichols Institute | CDP |
| Feb 25, 1993 | K926345 | TRIODOTHYRONINE (TC) COATED TUBE RIA Monobind | CDP |
| Dec 28, 1992 | K925436 | MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CDP |
| Oct 15, 1992 | K923571 | VISTA TRIIODOTHYRONINE ASSAY Syva Co. | CDP |
| Oct 14, 1992 | K922771 | KODAK AMERLEX MAB FT3 ASSAY Eastman Kodak Company | CDP |
| Sep 23, 1992 | K923258 | TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE Heraeus Kulzer, Inc. | CDP |
| Sep 2, 1992 | K923015 | TOTAL T3 CHEMILUMINESCENCE ASSAY Nichols Institute Diagnostics | CDP |
| Feb 6, 1992 | K915792 | DOCUMENT CK ISOENZYMES CONTROL Casco Standards | CDP |
| Feb 6, 1992 | K914467 | MILENIA TOTAL T3 Diagnostic Products Corp. | CDP |
| May 1, 1991 | K910737 | SRI T3 IMMOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CDP |
| Feb 4, 1991 | K905410 | OPUS T3 TEST SYSTEM Pb Diagnostic Systems, Inc. | CDP |
| Feb 1, 1991 | K905214 | IMMULITE (TM) TOTAL T3 Cirrus Diagnostics, Inc. | CDP |
| Jan 23, 1991 | K905656 | FLAGEN TRIIODOTHYRONINE (T3) ASSAY Cyberfluor, Inc., CA | CDP |
| Jan 23, 1991 | K905261 | IMX FREE TRIIODOTHYRONINE Abbott Laboratories | CDP |
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