FDA Product Code
FDA Product Code CDX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1700
510(k) Clearances — 121 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K961490 | ELECSYS T4 ASSAY | Boehringer Mannheim Corp. | 1996-06-13 | Traditional | PDF ↗ |
| K954312 | ACTIVE THYROXINE RIA | Diagnostic Systems Laboratories, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K943416 | DELFIA NEONATAL THYROXINE KIT | Wallac OY | 1995-03-10 | Traditional | PDF ↗ |
| K934384 | AXSYM(TM) TOTAL T4 | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K932980 | TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 | Sigma Diagnostics, Inc. | 1993-10-18 | Traditional | PDF ↗ |
| K933426 | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO | Baxter Diagnostics, Inc. | 1993-08-26 | Traditional | PDF ↗ |
| K931295 | IQ TT4 ASSAY | Becton Dickinson Advanced Diagnostics | 1993-07-20 | Traditional | PDF ↗ |
| K926563 | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT | Bio-Chem Laboratory Systems, Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K925110 | ABBOTT IMX T4 | Abbott Laboratories | 1993-01-26 | Traditional | PDF ↗ |
| K925109 | ABBOTT TDX/TDXFLX TT4 | Abbott Laboratories | 1993-01-04 | Traditional | PDF ↗ |
| K922945 | TECHNICON DAX SYSTEM THYROXINE (T4) METHOD | Heraeus Kulzer, Inc. | 1992-10-14 | Traditional | PDF ↗ |
| K921935 | THYROXINE (T4) COATED TUBE RIA | Monobind | 1992-07-07 | Traditional | PDF ↗ |
| K920766 | T4 EIA BEAD ASSAY | Tech-Co, Inc. | 1992-04-17 | Traditional | PDF ↗ |
| K915235 | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT | Incstar Corp. | 1992-01-28 | Traditional | PDF ↗ |
| K912541 | MILENIA TOTAL T4, CATALOG: MKT41,5 | Diagnostic Products Corp. | 1991-08-12 | Traditional | PDF ↗ |
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | London Diagnostics, Inc. | 1991-08-02 | Traditional | PDF ↗ |
| K904816 | THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-01-17 | Traditional | PDF ↗ |
| K905532 | CIBA CORNING ACS T4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-01-15 | Traditional | PDF ↗ |
| K902922 | MICROZYME T4 ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1990-07-27 | Traditional | PDF ↗ |
| K901475 | CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 | Baxter Healthcare Corp | 1990-06-20 | Traditional | PDF ↗ |
| K901939 | NEOCOAT T4 | Neometrics, Inc. | 1990-05-31 | Traditional | PDF ↗ |
| K894575 | TECHNICON RA SYSTEM THYROXINE T4 METHOD | Technicon Instruments Corp. | 1989-10-04 | Traditional | PDF ↗ |
| K883559 | DELFIA THYROXINE (T4) KIT | Pharmacia, Inc. | 1988-12-14 | Traditional | PDF ↗ |
| K874623 | FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 | Cyberfluor, Inc. | 1988-02-16 | Traditional | PDF ↗ |
| K875081 | IMMPULSE T4 ASSAY REAGENTS | Sclavo, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K872286 | CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1987-07-21 | Traditional | PDF ↗ |
| K871303 | DELFIA(TM) THYROXINE (T4) KIT | Lkb Instruments, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K871008 | MICROMEDIC NEONATAL T4 KIT | Micromedic Systems | 1987-05-26 | Traditional | PDF ↗ |
| K870965 | CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1987-05-14 | Traditional | PDF ↗ |
| K870573 | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT | Cambridge Medical Technology | 1987-04-22 | Traditional | PDF ↗ |
| K864560 | IQ T4 IMMUNOASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-12-16 | Traditional | PDF ↗ |
| K861320 | MMS T4 RIA KIT | Micromedic Systems | 1986-04-24 | Traditional | PDF ↗ |
| K860421 | STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY | American Dade | 1986-02-11 | Traditional | PDF ↗ |
| K854798 | T-4 RIASSAY | Ria Diagnostics | 1986-01-15 | Traditional | PDF ↗ |
| K854324 | PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1985-12-05 | Traditional | PDF ↗ |
| K840852 | IMMPULSE T4 ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-18 | Traditional | PDF ↗ |
| K834023 | BIO-SCIENCE LABORATORIES T4 REAGENT | Biosan Laboratories, Inc. | 1984-01-24 | Traditional | PDF ↗ |
| K833850 | T4 RIA | Syncor Intl. Corp. | 1984-01-18 | Traditional | PDF ↗ |
| K833745 | RIACOAT T-4 | Immuno Assay Corp. | 1984-01-04 | Traditional | PDF ↗ |
| K832468 | T4-RIA SINGLE REAGENT | Fairlake Laboratories | 1983-09-12 | Traditional | PDF ↗ |
| K831533 | MAGIC T4 125I RADIOIMMUNOASSAY | Corning Medical & Scientific | 1983-06-30 | Traditional | PDF ↗ |
| K831107 | COAT-A-COUNT NEONATAL T4 KIT RIA KIT | Diagnostic Products Corp. | 1983-05-18 | Traditional | PDF ↗ |
| K830642 | PHASE THYROXINE RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K823265 | MONOCLONAL ANTIBODY T4 RADIO-KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-12-09 | Traditional | PDF ↗ |
| K823053 | NML-TETRA-TUBE RIA | Nuclear Medical Laboratories, Inc. | 1982-11-10 | Traditional | PDF ↗ |
| K823004 | BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-11-05 | Traditional | PDF ↗ |
| K822399 | LEECO T4 QUANT DIAGNOSTICS TEST KIT | Leeco Diagnostics, Inc. | 1982-09-13 | Traditional | PDF ↗ |
| K821554 | ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT | Amf Biological and Diagnostics Co. | 1982-06-25 | Traditional | PDF ↗ |
| K820725 | SPAC T4 RIA TEST KIT | Mallinckrodt Critical Care | 1982-06-01 | Traditional | PDF ↗ |
| K821141 | ENDAB T4 ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1982-05-13 | Traditional | PDF ↗ |
| K821101 | TOTAL RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-05-05 | Traditional | PDF ↗ |
| K820886 | THYROXINE T4 KIT | Pcl-Ria, Inc. | 1982-04-16 | Traditional | PDF ↗ |
| K811787 | QUANTAPHASE T-4 RIA | Bio-Rad | 1981-07-10 | Traditional | PDF ↗ |
| K811315 | COAT-A-COUNT T4 RIA KIT | Diagnostic Products Corp. | 1981-05-27 | Traditional | PDF ↗ |
| K811070 | 125 I-T4 RIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K810811 | T4 RIA KIT | Immuno Assay Corp. | 1981-04-07 | Traditional | PDF ↗ |
| K803046 | IMMU-TRACE T4 RIA PROCEDURE | American Dade | 1981-01-02 | Traditional | PDF ↗ |
| K802573 | SERUM T4 BY ENZYME IMMUNOASSAY | Worthington Diagnostic Systems | 1980-11-24 | Traditional | PDF ↗ |
| K802469 | T4 RADIOIMMUNOASSAY KIT | American Diagnostic Corp. | 1980-11-12 | Traditional | PDF ↗ |
| K802456 | T4-SQUIBB RIA KIT | E. R. Squibb & Sons, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801105 | THYROXINE RADIOIMMUNOASSAY KIT | Calbiochem-Behring Corp. | 1980-06-09 | Traditional | PDF ↗ |
| K800203 | RIA PHASE T4 | Boehringer Mannheim Corp. | 1980-03-19 | Traditional | PDF ↗ |
| K800385 | ANALYTE T4-THYROXINE | Technicon Instruments Corp. | 1980-03-19 | Traditional | PDF ↗ |
| K800300 | AMERLEX T-4 RIA KIT | Amersham Corp. | 1980-03-05 | Traditional | PDF ↗ |
| K800187 | EMC-M-175, THYROXINE - 100 TUBES | Endocrine-Metabolic Center | 1980-02-13 | Traditional | PDF ↗ |
| K800169 | AMES RIALYZE - CHROMATOGRAPHY TUBES | Miles Laboratories, Inc. | 1980-02-13 | Traditional | PDF ↗ |
| K792599 | TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY | Nuclear Diagnostics, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792188 | TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT | Abbott Laboratories | 1979-11-27 | Traditional | PDF ↗ |
| K791664 | IMMUCHEM COVALENT COAT SOLID PHASE ASSAY | Immuchem Corp. | 1979-09-27 | Traditional | PDF ↗ |
| K791368 | VENTRE/SEP T4 TEST SET | Ventrex Laboratories, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K791231 | DAC-CEL T4 | Burroughs Wellcome Co. | 1979-09-04 | Traditional | PDF ↗ |
| K790576 | QUANTIMUNE T-4 FIA | Bio-Rad | 1979-07-30 | Traditional | PDF ↗ |
| K790907 | AUTOPAK TEST DELIVERY SYSTEM | Micromedic Systems | 1979-06-27 | Traditional | PDF ↗ |
| K790800 | CENTRIA T4 RIA TEST SET | Ventrex Laboratories, Inc. | 1979-06-15 | Traditional | PDF ↗ |
| K790665 | NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM | Micromedic Systems | 1979-05-15 | Traditional | PDF ↗ |
| K790495 | THYROXINE RIA KIT | Technia Diagnostics , Ltd. | 1979-05-03 | Traditional | PDF ↗ |
| K790477 | TY RIA KIT, AUTOMATED ASSAY SYSTEM | E. R. Squibb & Sons, Inc. | 1979-04-26 | Traditional | PDF ↗ |
| K782109 | RIA KIT, GAMMACOAT | Clinical Assays, Inc. | 1979-01-26 | Traditional | PDF ↗ |
| K782103 | RIA KIT, NEONATAL T4 | Serono Laboratories, Inc. | 1979-01-17 | Traditional | PDF ↗ |
| K781222 | ACCUSCREEN T4 | Neometrics, Inc. | 1978-11-08 | Traditional | PDF ↗ |
| K781483 | ORTHO*T-4 RIA (PEG) KIT | Ortho Diagnostics, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K781182 | MICRO THYROXINE REAGENT SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-14 | Traditional | PDF ↗ |
| K781235 | IV VITRO GAMMADAB T4 RIA KIT | Clinical Assays, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K781181 | CLINIRIA TOTAL T-4 (RIA) TEST | Miles Laboratories, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K780854 | IN VITRO NEONATAL T4 | Clinical Assays, Inc. | 1978-07-27 | Traditional | PDF ↗ |
| K780707 | T4-RIA KIT | Clinical Bioresearch | 1978-06-14 | Traditional | PDF ↗ |
| K780672 | 125 I-T4 RIA REAGENT | Radioimmunoassay, Inc. | 1978-06-06 | Traditional | PDF ↗ |
| K780639 | EMIT CENTRIFICHEM THYROXINE ASSAY | Syva Co. | 1978-05-03 | Traditional | PDF ↗ |
| K780644 | RADIOASSAY FOR TOTAL SERUM THYROXINE | Nuclear Diagnostics, Inc. | 1978-04-28 | Traditional | PDF ↗ |
| K780401 | THYRO-ZYME-T4 ASSAY KIT | Coulter Electronics, Inc. | 1978-04-24 | Traditional | PDF ↗ |
| K780308 | OREIA-T4 | Organon, Inc. | 1978-04-12 | Traditional | PDF ↗ |
| K780423 | STIKSEP-T4 RIA KIT | Nuclear Diagnostics, Inc. | 1978-03-30 | Traditional | PDF ↗ |
| K780121 | REAGENTS, MANUEAL, ASSAY, THYROXINE | Syva Co. | 1978-03-17 | Traditional | PDF ↗ |
| K780219 | ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY | Syva Co. | 1978-03-03 | Traditional | PDF ↗ |
| K780050 | THYROXINE STDS. IN HUMAN SERUM | Pcl-Ria, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K772330 | T4 RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-01-12 | Traditional | PDF ↗ |
| K771415 | RIA FOR SERUM THYROXINE | Clinical Immuno-Diagnostics | 1978-01-05 | Traditional | PDF ↗ |
| K772170 | EMIT CENTRIFICHEM THYROXINE ASSAY | Syva Co. | 1977-12-22 | Traditional | PDF ↗ |
| K771609 | PEDIATRIC THYROXINE TEST SYS. T4 | Corning Medical & Scientific | 1977-12-20 | Traditional | PDF ↗ |
| K772096 | IN VITRO DIAGNOSTIC REAGENT | Pcl-Ria, Inc. | 1977-11-22 | Traditional | PDF ↗ |
Product code CDX · Class II · Clinical Chemistry. Data: openFDA.