ClearanceBrief
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)
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Top companies in CDP

Company510(k)sRecalls
Abbott Laboratories130
Amersham Corp.70
Beckman Coulter Inc.07
Diagnostic Products Corp.60
Boehringer Mannheim Corp.40
Tosoh Bioscience Inc04
Abbott Ireland Diagnostics Division03
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Bio-Rad Laboratories, Inc.30
E. R. Squibb & Sons, Inc.30
Decided510(k)Device and applicantCode
Apr 7, 1981K810798TECHNICON STAR SYSTEM T3 RIA METHOD
Technicon Instruments Corp.
CDP
Feb 23, 1981K810351RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE
Endocrine-Metabolic Center
CDP
Feb 10, 1981K810211T3 RIA KIT
E. R. Squibb & Sons, Inc.
CDP
Jan 15, 1981K803261T3 RIABEAD DIAGNOSTIC KIT
Abbott Laboratories
CDP
Jan 9, 1981K8031801-125 LABELED TRIIODOTHYRONINE(T3)
Pcl-Ria, Inc.
CDP
Dec 19, 1980K802883T3-SQUIBB RIA KIT
E. R. Squibb & Sons, Inc.
CDP
Nov 12, 1980K802470T3 RADIOIMMUNOASSAY KIT
American Diagnostic Corp.
CDP
Sep 16, 1980K801843T3(125) RADIOIMMUNOASSAY KIT
Technia Diagnostics , Ltd.
CDP
Jun 9, 1980K801125SPAC T3 RIA TEST KIT
Mallinckrodt Critical Care
CDP
Jun 9, 1980K801123TRIIODOTHYRONINE RADIOIMMUN. SYSTEM
Calbiochem-Behring Corp.
CDP
Mar 19, 1980K800436T3 SOLID PHASE RADIOIMMUNOASSAY KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDP
Mar 12, 1980K800374AMERLEX T-3 RIA KIT
Amersham Corp.
CDP
Jan 16, 1980K792539TRIIODOTHYRONINE RIA SYSTEM
Radioimmunoassay, Inc.
CDP
Oct 11, 1979K791375AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM
Micromedic Systems
CDP
Oct 1, 1979K791663IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
Immuchem Corp.
CDP
Sep 27, 1979K791588VENTRE/SEP T3 TEST SET
Ventrex Laboratories, Inc.
CDP
Sep 17, 1979K791317IREX REAL TIME PHASED ARRAY SYSTEM
Irex Corp.
CDP
Sep 4, 1979K791232DAC-CEL T3
Burroughs Wellcome Co.
CDP
Aug 10, 1979K790960QUANTIMUNE T-3 FIA
Bio-Rad
CDP
Jun 27, 1979K790908RIA, TEST SET CENTRIA T3
Ventrex Laboratories, Inc.
CDP
May 15, 1979K790581CHROMATOGRAPHY TUBES
Miles Laboratories, Inc.
CDP
Sep 27, 1978K781481ORTHO*T-3 RIA (PEG) KIT
Ortho Diagnostics, Inc.
CDP
Aug 31, 1978K781284RABBIT ANTIBODY TO HUMAN T3
Pcl-Ria, Inc.
CDP
Jun 6, 1978K780787TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDP
May 4, 1978K780499CBR-T3RIA KIT
Clinical Bioresearch
CDP
Apr 28, 1978K780492GAMMA STIK 125I T3 UPTAKE KIT
Alpha Gamma Laboratory
CDP
Mar 2, 1978K780292TRIA-PEG RIA DIAG. KIT
Nuclear Diagnostics, Inc.
CDP
Feb 7, 1978K780018THYRO-INDICATOR T-3 125I
Clinical Immuno-Diagnostics
CDP
Dec 22, 1977K772177TRI-TAB-RIA
Nuclear Medical Laboratories, Inc.
CDP
Nov 17, 1977K772122T3 RIA KIT
Antibodies, Inc.
CDP
Nov 17, 1977K772108IN VITRO T3 RIA TEST
Clinical Assays, Inc.
CDP
Sep 20, 1977K771623T3 RIA
Hoffmann-La Roche, Inc.
CDP
Aug 4, 1977K771220T3 RIA TEST SYSTEM
Monobind
CDP
Jul 14, 1977K771142T3 CLASP RIA KIT
E. R. Squibb & Sons, Inc.
CDP
Jun 22, 1977K770739SERUM SET, THYROID CONTROL
G.D. Searle and Co.
CDP
Jun 22, 1977K770738REAGENT, T-3 UPTAKE
G.D. Searle and Co.
CDP
Jun 17, 1977K770918LIQUI SOL T4 RIA TEST KIT
Damon Corp.
CDP
Jun 14, 1977K770648QUANTIMUNE T-3 RIA
Bio-Rad
CDP
Jun 3, 1977K770520RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3
Kallestad Laboratories, Inc.
CDP
May 20, 1977K770677T-3 RIA REAGENT SET
G.D. Searle and Co.
CDP
Apr 5, 1977K770201T3 RIA (PEG) DIAGNOSTIC KIT
Abbott Laboratories
CDP
Dec 30, 1976K761305CENTRIA T3 RIA
Union Carbide Corp.
CDP
Sep 13, 1976K760057TEST, RIA, TRIODOTHYRONINE
Smithkline Diagnostics, Inc.
CDP
Jul 20, 1976K760078REAGENT, RIA TRIIODOTHYRONINE T3 (#200)
Oxford Laboratories, Inc.
CDP

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