FDA Product Code
FDA Product Code CDP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1710
510(k) Clearances — 144 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001607 | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | Repromedix Corp. | 2000-10-05 | Traditional | PDF ↗ |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | Chiron Diagnostics Corp. | 1999-06-18 | Traditional | PDF ↗ |
| K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | Biocheck, Inc. | 1999-06-02 | Traditional | PDF ↗ |
| K991252 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | 1999-05-11 | Traditional | PDF ↗ |
| K981824 | OPTICOAT T3 EIA KIT | Biotecx Laboratories, Inc. | 1998-12-22 | Traditional | PDF ↗ |
| K983434 | ABBOTT ARCHITECT TOTAL T3 | Abbott Laboratories | 1998-11-20 | Traditional | PDF ↗ |
| K983439 | ABBOTT ARCHITECT FREE T3 | Abbott Laboratories | 1998-11-20 | Traditional | PDF ↗ |
| K974027 | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK | Alfa Biotech (Uk) , Ltd. | 1998-02-02 | Traditional | PDF ↗ |
| K974634 | IMMULITE FREE T3 | Diagnostic Products Corp. | 1998-01-02 | Traditional | PDF ↗ |
| K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1997-10-31 | Traditional | PDF ↗ |
| K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | Monobind | 1997-06-16 | Traditional | PDF ↗ |
| K971270 | DSL ACTIVE T3 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K965058 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | Nichols Institute Diagnostics | 1997-03-11 | Traditional | PDF ↗ |
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-30 | Traditional | PDF ↗ |
| K963127 | ELECSYS FT3 | Boehringer Mannheim Corp. | 1996-12-16 | Traditional | PDF ↗ |
| K962760 | ENZYMUN-TEST FT3 | Boehringer Mannheim Corp. | 1996-11-29 | Traditional | PDF ↗ |
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K963687 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | 1996-11-08 | Traditional | PDF ↗ |
| K963833 | IMX FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | 1996-10-30 | Traditional | PDF ↗ |
| K963827 | AXSYM FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | 1996-10-30 | Traditional | PDF ↗ |
| K962508 | ELECSYS T3 | Boehringer Mannheim Corp. | 1996-08-15 | Traditional | PDF ↗ |
| K962355 | FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1996-07-12 | Traditional | PDF ↗ |
| K961236 | UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE | United Biotech, Inc. | 1996-05-30 | Traditional | PDF ↗ |
| K960913 | ACCESS FREE T3 ASSAY | Bio-Rad Laboratories, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K960412 | T-3 MICROWELL EIA MODEL 7013 | Biomerica, Inc. | 1996-03-19 | Traditional | PDF ↗ |
| K960550 | ACTIVE T3 RIA | Diagnostic Systems Laboratories, Inc. | 1996-03-06 | Traditional | PDF ↗ |
| K955435 | ACCESS TOTAL T3 ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K952557 | TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS | Sigma Diagnostics, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K953160 | OPUS T3 | Behring Diagnostics, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K944808 | IMX T3 ASSAY | Organon Teknika Corp. | 1994-12-09 | Traditional | PDF ↗ |
| K940833 | ACCESS(R) TOTAL T3 | Bio-Rad Laboratories, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K936229 | AIA-PACK TT3 ASSAY | Tosoh Medics, Inc. | 1994-07-14 | Traditional | PDF ↗ |
| K934517 | AXSYM TOTAL T3 | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K934764 | VIDAS T3 ASSAY | Biomerieux Vitek, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K932747 | CIBA CORNING ACS FREE T3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-03 | Traditional | PDF ↗ |
| K932608 | COBAS(R) CORE T3 EIA | Roche Diagnostic Systems, Inc. | 1993-12-03 | Traditional | PDF ↗ |
| K931600 | CHEMILUMINESCENCE FREE T3 IMMUNOASSAY | Nichols Institute | 1993-09-08 | Traditional | PDF ↗ |
| K926345 | TRIODOTHYRONINE (TC) COATED TUBE RIA | Monobind | 1993-02-25 | Traditional | PDF ↗ |
| K925436 | MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K923571 | VISTA TRIIODOTHYRONINE ASSAY | Syva Co. | 1992-10-15 | Traditional | PDF ↗ |
| K922771 | KODAK AMERLEX MAB FT3 ASSAY | Eastman Kodak Company | 1992-10-14 | Traditional | PDF ↗ |
| K923258 | TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE | Heraeus Kulzer, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K923015 | TOTAL T3 CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | 1992-09-02 | Traditional | PDF ↗ |
| K915792 | DOCUMENT CK ISOENZYMES CONTROL | Casco Standards | 1992-02-06 | Traditional | PDF ↗ |
| K914467 | MILENIA TOTAL T3 | Diagnostic Products Corp. | 1992-02-06 | Traditional | PDF ↗ |
| K910737 | SRI T3 IMMOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K905410 | OPUS T3 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-02-04 | Traditional | PDF ↗ |
| K905214 | IMMULITE (TM) TOTAL T3 | Cirrus Diagnostics, Inc. | 1991-02-01 | Traditional | PDF ↗ |
| K905261 | IMX FREE TRIIODOTHYRONINE | Abbott Laboratories | 1991-01-23 | Traditional | PDF ↗ |
| K905656 | FLAGEN TRIIODOTHYRONINE (T3) ASSAY | Cyberfluor, Inc. | 1991-01-23 | Traditional | PDF ↗ |
| K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1990-12-18 | Traditional | PDF ↗ |
| K903433 | TDX FREE T3 CALCULATION | Abbott Laboratories | 1990-10-12 | Traditional | PDF ↗ |
| K904098 | CEDIA TOTAL T3 ASSAY | Microgenics Corp. | 1990-09-27 | Traditional | PDF ↗ |
| K903432 | IMX FREE T3 CALCULATION | Abbott Laboratories | 1990-09-07 | Traditional | PDF ↗ |
| K897001 | TOSOH AIA-PACK T3 | Tosoh Corp. | 1990-03-09 | Traditional | PDF ↗ |
| K896900 | ENZYMUN TEST R T3 | Boehringer Mannheim Corp. | 1990-02-08 | Traditional | PDF ↗ |
| K894238 | ABBOTT TDX TOTAL T3 PLUS | Abbott Laboratories | 1989-10-31 | Traditional | PDF ↗ |
| K895840 | MILENIA(TM) TOTAL T4 (MKT41,5) | Diagnostic Products Corp. | 1989-10-19 | Traditional | PDF ↗ |
| K894993 | STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. | Baxter Healthcare Corp | 1989-10-13 | Traditional | PDF ↗ |
| K894200 | FREE T3 RADIOIMMUNOASSAY KIT | Advanced Magnetics, Inc. | 1989-09-25 | Traditional | PDF ↗ |
| K893620 | T3 CLASP-BEAD EIA KIT | Biotecx Laboratories, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K885195 | AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT | Amersham Corp. | 1989-02-08 | Traditional | PDF ↗ |
| K883810 | DELFIA TRIIODOTHYRONINE (T3) KIT | Pharmacia, Inc. | 1988-12-02 | Traditional | PDF ↗ |
| K883479 | STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME | Baxter Healthcare Corp | 1988-10-25 | Traditional | PDF ↗ |
| K881214 | IMMPULSE T, ASSAY REAGENTS | Sclavo, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K881373 | AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT | Amersham Corp. | 1988-05-27 | Traditional | PDF ↗ |
| K880087 | ABBOTT IMX T3 | Abbott Laboratories | 1988-04-18 | Traditional | PDF ↗ |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | Serono Diagnostics, Inc. | 1988-03-03 | Traditional | PDF ↗ |
| K873737 | NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY | Cambridge Medical Technology | 1987-11-24 | Traditional | PDF ↗ |
| K873945 | CIBA CORNING MAGIC LITE T3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1987-11-23 | Traditional | PDF ↗ |
| K873858 | AMERLITE TT3 ASSAY, LAN.0003/1003/2003 | Amersham Corp. | 1987-11-03 | Traditional | PDF ↗ |
| K872191 | IMMUBEAD T3 ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1987-08-13 | Traditional | PDF ↗ |
| K870968 | TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | Canadian Bioclinical, Ltd. | 1987-06-22 | Traditional | PDF ↗ |
| K864452 | DELFIA(TM) TRIIODOTHYRONINE (T3) KIT | Lkb Instruments, Inc. | 1987-02-02 | Traditional | PDF ↗ |
| K860252 | AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA | Amersham Corp. | 1986-02-11 | Traditional | PDF ↗ |
| K853703 | VENTREZYME T3 IMMUNOASSAY T3 | Vxr, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K852537 | T-3 RIASSAY | Ria Diagnostics | 1985-08-12 | Traditional | PDF ↗ |
| K851676 | TDX TOTAL T3 | Abbott Laboratories | 1985-05-20 | Traditional | PDF ↗ |
| K842949 | AMERLEX-M FREE T-3 RIA | Amersham Corp. | 1984-09-05 | Traditional | PDF ↗ |
| K842590 | AMER. BIO-SCIENCE LAB T3 REAGENTS | American Bio-Science Laboratories | 1984-08-10 | Traditional | PDF ↗ |
| K840222 | CORNING IMMO PHASE FREE T3 | Corning Medical & Scientific | 1984-05-07 | Traditional | PDF ↗ |
| K840959 | FREE T3 SOLID PHASE RADIOIMMUNOASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-04-18 | Traditional | PDF ↗ |
| K840050 | SOPHEIA T3 EIA KIT | Diagnostic Products Corp. | 1984-03-19 | Traditional | PDF ↗ |
| K834348 | LEECO T3-QUANT DIAG. KIT | Leeco Diagnostics, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K833853 | T3 RIA | Syncor Intl. Corp. | 1984-02-04 | Traditional | PDF ↗ |
| K834049 | ENDAB T3 | Immunotech Corp. | 1984-01-30 | Traditional | PDF ↗ |
| K832164 | COAT-A-COUNT FREE T3 RIA KIT | Diagnostic Products Corp. | 1983-10-27 | Traditional | PDF ↗ |
| K832469 | T3-RIA SINGLE REAGENT | Fairlake Laboratories | 1983-09-12 | Traditional | PDF ↗ |
| K832353 | CORNING'S MAGIC T3(125I) RADIOIMMUNO- | Corning Medical & Scientific | 1983-08-31 | Traditional | PDF ↗ |
| K831434 | ISO-SEP SYSTEM | Berwick Medical Products, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K830980 | AMERLEX FREE T-3 RIA KIT | Amersham Corp. | 1983-05-25 | Traditional | PDF ↗ |
| K831064 | PHASE II T3 RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830808 | LEECO T3-RIA DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1983-04-08 | Traditional | PDF ↗ |
| K821725 | T3 DIAGNOSTIC KIT RIA | Diagnostic Reagents, Inc. | 1982-06-24 | Traditional | PDF ↗ |
| K820251 | T4 DIAGNOSTIC KIT | Diagnostic Reagents, Inc. | 1982-05-05 | Traditional | PDF ↗ |
| K820763 | ENZYM-LINKED T3 | Icl Scientific | 1982-04-15 | Traditional | PDF ↗ |
| K812611 | QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO | Kallestad Laboratories, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K812666 | THYROXINE (T4) 125I | Pcl-Ria, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K812246 | COAT-A-COUNT T3 RIA KIT | Diagnostic Products Corp. | 1981-08-20 | Traditional | PDF ↗ |
| K811213 | T3 (RIA) KIT | Immuno Assay Corp. | 1981-05-29 | Traditional | PDF ↗ |
Product code CDP · Class II · Clinical Chemistry. Data: openFDA.