Panels › Clinical Chemistry › Product code CDX · Class 2
Radioimmunoassay, Total Thyroxine
Regulation 862.1700
0510(k)s in 12 months (121 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in CDX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 1996 | K961490 | ELECSYS T4 ASSAY Boehringer Mannheim Corp. | CDX |
| Oct 7, 1995 | K954312 | ACTIVE THYROXINE RIA Diagnostic Systems Laboratories, Inc. | CDX |
| Mar 10, 1995 | K943416 | DELFIA NEONATAL THYROXINE KIT Wallac OY, FI | CDX |
| Jun 21, 1994 | K934384 | AXSYM(TM) TOTAL T4 Abbott Laboratories | CDX |
| Oct 18, 1993 | K932980 | TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 Sigma Diagnostics, Inc. | CDX |
| Aug 26, 1993 | K933426 | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO Baxter Diagnostics, Inc. | CDX |
| Jul 20, 1993 | K931295 | IQ TT4 ASSAY Becton Dickinson Advanced Diagnostics | CDX |
| Mar 18, 1993 | K926563 | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT Bio-Chem Laboratory Systems, Inc. | CDX |
| Jan 26, 1993 | K925110 | ABBOTT IMX T4 Abbott Laboratories | CDX |
| Jan 4, 1993 | K925109 | ABBOTT TDX/TDXFLX TT4 Abbott Laboratories | CDX |
| Oct 14, 1992 | K922945 | TECHNICON DAX SYSTEM THYROXINE (T4) METHOD Heraeus Kulzer, Inc. | CDX |
| Jul 7, 1992 | K921935 | THYROXINE (T4) COATED TUBE RIA Monobind | CDX |
| Apr 17, 1992 | K920766 | T4 EIA BEAD ASSAY Tech-Co, Inc. | CDX |
| Jan 28, 1992 | K915235 | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT Incstar Corp. | CDX |
| Aug 12, 1991 | K912541 | MILENIA TOTAL T4, CATALOG: MKT41,5 Diagnostic Products Corp. | CDX |
| Aug 2, 1991 | K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY London Diagnostics, Inc. | CDX |
| Jan 17, 1991 | K904816 | THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM Bd Becton Dickinson Vacutainer Systems Preanalytic | CDX |
| Jan 15, 1991 | K905532 | CIBA CORNING ACS T4 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CDX |
| Jul 27, 1990 | K902922 | MICROZYME T4 ENZYME IMMUNOASSAY KIT Immunotech Corp. | CDX |
| Jun 20, 1990 | K901475 | CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 Baxter Healthcare Corp | CDX |
| May 31, 1990 | K901939 | NEOCOAT T4 Neometrics, Inc. | CDX |
| Oct 4, 1989 | K894575 | TECHNICON RA SYSTEM THYROXINE T4 METHOD Technicon Instruments Corp. | CDX |
| Dec 14, 1988 | K883559 | DELFIA THYROXINE (T4) KIT Pharmacia, Inc. | CDX |
| Feb 16, 1988 | K874623 | FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 Cyberfluor, Inc., CA | CDX |
| Feb 11, 1988 | K875081 | IMMPULSE T4 ASSAY REAGENTS Sclavo, Inc. | CDX |
| Jul 21, 1987 | K872286 | CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CDX |
| Jun 17, 1987 | K871303 | DELFIA(TM) THYROXINE (T4) KIT Lkb Instruments, Inc. | CDX |
| May 26, 1987 | K871008 | MICROMEDIC NEONATAL T4 KIT Micromedic Systems | CDX |
| May 14, 1987 | K870965 | CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CDX |
| Apr 22, 1987 | K870573 | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT Cambridge Medical Technology | CDX |
| Dec 16, 1986 | K864560 | IQ T4 IMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | CDX |
| Apr 24, 1986 | K861320 | MMS T4 RIA KIT Micromedic Systems | CDX |
| Feb 11, 1986 | K860421 | STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY American Dade | CDX |
| Jan 15, 1986 | K854798 | T-4 RIASSAY Ria Diagnostics | CDX |
| Dec 5, 1985 | K854324 | PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. | CDX |
| Apr 18, 1984 | K840852 | IMMPULSE T4 ASSAY REAGENTS Paragon Diagnostics, Inc. | CDX |
| Jan 24, 1984 | K834023 | BIO-SCIENCE LABORATORIES T4 REAGENT Biosan Laboratories, Inc. | CDX |
| Jan 18, 1984 | K833850 | T4 RIA Syncor Intl. Corp. | CDX |
| Jan 4, 1984 | K833745 | RIACOAT T-4 Immuno Assay Corp. | CDX |
| Sep 12, 1983 | K832468 | T4-RIA SINGLE REAGENT Fairlake Laboratories | CDX |
| Jun 30, 1983 | K831533 | MAGIC T4 125I RADIOIMMUNOASSAY Corning Medical & Scientific | CDX |
| May 18, 1983 | K831107 | COAT-A-COUNT NEONATAL T4 KIT RIA KIT Diagnostic Products Corp. | CDX |
| Apr 5, 1983 | K830642 | PHASE THYROXINE RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. | CDX |
| Dec 9, 1982 | K823265 | MONOCLONAL ANTIBODY T4 RADIO-KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | CDX |
| Nov 10, 1982 | K823053 | NML-TETRA-TUBE RIA Nuclear Medical Laboratories, Inc. | CDX |
| Nov 5, 1982 | K823004 | BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT Bioclinical Group | CDX |
| Sep 13, 1982 | K822399 | LEECO T4 QUANT DIAGNOSTICS TEST KIT Leeco Diagnostics, Inc. | CDX |
| Jun 25, 1982 | K821554 | ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT Amf Biological and Diagnostics Co. | CDX |
| Jun 1, 1982 | K820725 | SPAC T4 RIA TEST KIT Mallinckrodt Critical Care | CDX |
| May 13, 1982 | K821141 | ENDAB T4 ENZYME IMMUNOASSAY KIT Immunotech Corp. | CDX |
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