Atlas FDA

CDX

121 FDA 510(k) clearances · Product code

38 daysmedian time to decision
88 days90th percentile
121clearances measured

FDA profile

Official device name
Radioimmunoassay, Total Thyroxine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1700
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
1997: 1 · 2003: 1 · 2004: 1 · 2011: 6 · 2018: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ELECSYS T4 ASSAY (K961490)Boehringer Mannheim Corp.1996-06-13
ACTIVE THYROXINE RIA (K954312)Diagnostic Systems Laboratories, Inc.1995-10-07
DELFIA NEONATAL THYROXINE KIT (K943416)Wallac OY1995-03-10
AXSYM(TM) TOTAL T4 (K934384)Abbott Laboratories1994-06-21
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (K932980)Sigma Diagnostics, Inc.1993-10-18
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (K933426)Baxter Diagnostics, Inc.1993-08-26
IQ TT4 ASSAY (K931295)Becton Dickinson Advanced Diagnostics1993-07-20
AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (K926563)Bio-Chem Laboratory Systems, Inc.1993-03-18
ABBOTT IMX T4 (K925110)Abbott Laboratories1993-01-26
ABBOTT TDX/TDXFLX TT4 (K925109)Abbott Laboratories1993-01-04
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD (K922945)Heraeus Kulzer, Inc.1992-10-14
THYROXINE (T4) COATED TUBE RIA (K921935)Monobind1992-07-07
T4 EIA BEAD ASSAY (K920766)Tech-Co, Inc.1992-04-17
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT (K915235)Incstar Corp.1992-01-28
MILENIA TOTAL T4, CATALOG: MKT41,5 (K912541)Diagnostic Products Corp.1991-08-12
LUMATAG T4 CHEMILUMINESCENCE ASSAY (K911985)London Diagnostics, Inc.1991-08-02
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM (K904816)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-01-17
CIBA CORNING ACS T4 IMMUNOASSAY (K905532)Ciba Corning Diagnostics Corp.1991-01-15
MICROZYME T4 ENZYME IMMUNOASSAY KIT (K902922)Immunotech Corp.1990-07-27
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 (K901475)Baxter Healthcare Corp1990-06-20
NEOCOAT T4 (K901939)Neometrics, Inc.1990-05-31
TECHNICON RA SYSTEM THYROXINE T4 METHOD (K894575)Technicon Instruments Corp.1989-10-04
DELFIA THYROXINE (T4) KIT (K883559)Pharmacia, Inc.1988-12-14
FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 (K874623)Cyberfluor, Inc.1988-02-16
IMMPULSE T4 ASSAY REAGENTS (K875081)Sclavo, Inc.1988-02-11
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY (K872286)Ciba Corning Diagnostics Corp.1987-07-21
DELFIA(TM) THYROXINE (T4) KIT (K871303)Lkb Instruments, Inc.1987-06-17
MICROMEDIC NEONATAL T4 KIT (K871008)Micromedic Systems1987-05-26
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY (K870965)Ciba Corning Diagnostics Corp.1987-05-14
T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT (K870573)Cambridge Medical Technology1987-04-22
IQ T4 IMMUNOASSAY (K864560)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
MMS T4 RIA KIT (K861320)Micromedic Systems1986-04-24
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY (K860421)American Dade1986-02-11
T-4 RIASSAY (K854798)Ria Diagnostics1986-01-15
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT (K854324)Pantex, Div. Bio-Analysis, Inc.1985-12-05
IMMPULSE T4 ASSAY REAGENTS (K840852)Paragon Diagnostics, Inc.1984-04-18
BIO-SCIENCE LABORATORIES T4 REAGENT (K834023)Biosan Laboratories, Inc.1984-01-24
T4 RIA (K833850)Syncor Intl. Corp.1984-01-18
RIACOAT T-4 (K833745)Immuno Assay Corp.1984-01-04
T4-RIA SINGLE REAGENT (K832468)Fairlake Laboratories1983-09-12
MAGIC T4 125I RADIOIMMUNOASSAY (K831533)Corning Medical & Scientific1983-06-30
COAT-A-COUNT NEONATAL T4 KIT RIA KIT (K831107)Diagnostic Products Corp.1983-05-18
PHASE THYROXINE RADIOIMMUNOASSAY KIT (K830642)Medical & Scientific Designs, Inc.1983-04-05
MONOCLONAL ANTIBODY T4 RADIO-KIT (K823265)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-12-09
NML-TETRA-TUBE RIA (K823053)Nuclear Medical Laboratories, Inc.1982-11-10
BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT (K823004)Bioclinical Group1982-11-05
LEECO T4 QUANT DIAGNOSTICS TEST KIT (K822399)Leeco Diagnostics, Inc.1982-09-13
ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT (K821554)Amf Biological and Diagnostics Co.1982-06-25
SPAC T4 RIA TEST KIT (K820725)Mallinckrodt Critical Care1982-06-01
ENDAB T4 ENZYME IMMUNOASSAY KIT (K821141)Immunotech Corp.1982-05-13
TOTAL RADIOIMMUNOASSAY KIT (K821101)Bioclinical Group1982-05-05
THYROXINE T4 KIT (K820886)Pcl-Ria, Inc.1982-04-16
QUANTAPHASE T-4 RIA (K811787)Bio-Rad1981-07-10
COAT-A-COUNT T4 RIA KIT (K811315)Diagnostic Products Corp.1981-05-27
125 I-T4 RIA TEST KIT (K811070)Intl. Immunoassay Laboratories, Inc.1981-04-29
T4 RIA KIT (K810811)Immuno Assay Corp.1981-04-07
IMMU-TRACE T4 RIA PROCEDURE (K803046)American Dade1981-01-02
SERUM T4 BY ENZYME IMMUNOASSAY (K802573)Worthington Diagnostic Systems1980-11-24
T4 RADIOIMMUNOASSAY KIT (K802469)American Diagnostic Corp.1980-11-12
T4-SQUIBB RIA KIT (K802456)E. R. Squibb & Sons, Inc.1980-10-31
THYROXINE RADIOIMMUNOASSAY KIT (K801105)Calbiochem-Behring Corp.1980-06-09
RIA PHASE T4 (K800203)Boehringer Mannheim Corp.1980-03-19
ANALYTE T4-THYROXINE (K800385)Technicon Instruments Corp.1980-03-19
AMERLEX T-4 RIA KIT (K800300)Amersham Corp.1980-03-05
AMES RIALYZE - CHROMATOGRAPHY TUBES (K800169)Miles Laboratories, Inc.1980-02-13
EMC-M-175, THYROXINE - 100 TUBES (K800187)Endocrine-Metabolic Center1980-02-13
TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY (K792599)Nuclear Diagnostics, Inc.1980-01-16
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT (K792188)Abbott Laboratories1979-11-27
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY (K791664)Immuchem Corp.1979-09-27
VENTRE/SEP T4 TEST SET (K791368)Ventrex Laboratories, Inc.1979-09-17
DAC-CEL T4 (K791231)Burroughs Wellcome Co.1979-09-04
QUANTIMUNE T-4 FIA (K790576)Bio-Rad1979-07-30
AUTOPAK TEST DELIVERY SYSTEM (K790907)Micromedic Systems1979-06-27
CENTRIA T4 RIA TEST SET (K790800)Ventrex Laboratories, Inc.1979-06-15
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM (K790665)Micromedic Systems1979-05-15
THYROXINE RIA KIT (K790495)Technia Diagnostics , Ltd.1979-05-03
TY RIA KIT, AUTOMATED ASSAY SYSTEM (K790477)E. R. Squibb & Sons, Inc.1979-04-26
RIA KIT, GAMMACOAT (K782109)Clinical Assays, Inc.1979-01-26
RIA KIT, NEONATAL T4 (K782103)Serono Laboratories, Inc.1979-01-17
ACCUSCREEN T4 (K781222)Neometrics, Inc.1978-11-08
ORTHO*T-4 RIA (PEG) KIT (K781483)Ortho Diagnostics, Inc.1978-09-27
MICRO THYROXINE REAGENT SYSTEM (K781182)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-08-14
CLINIRIA TOTAL T-4 (RIA) TEST (K781181)Miles Laboratories, Inc.1978-08-14
IV VITRO GAMMADAB T4 RIA KIT (K781235)Clinical Assays, Inc.1978-08-14
IN VITRO NEONATAL T4 (K780854)Clinical Assays, Inc.1978-07-27
T4-RIA KIT (K780707)Clinical Bioresearch1978-06-14
125 I-T4 RIA REAGENT (K780672)Radioimmunoassay, Inc.1978-06-06
EMIT CENTRIFICHEM THYROXINE ASSAY (K780639)Syva Co.1978-05-03
RADIOASSAY FOR TOTAL SERUM THYROXINE (K780644)Nuclear Diagnostics, Inc.1978-04-28
THYRO-ZYME-T4 ASSAY KIT (K780401)Coulter Electronics, Inc.1978-04-24
OREIA-T4 (K780308)Organon, Inc.1978-04-12
STIKSEP-T4 RIA KIT (K780423)Nuclear Diagnostics, Inc.1978-03-30
REAGENTS, MANUEAL, ASSAY, THYROXINE (K780121)Syva Co.1978-03-17
ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY (K780219)Syva Co.1978-03-03
THYROXINE STDS. IN HUMAN SERUM (K780050)Pcl-Ria, Inc.1978-02-13
T4 RIA KIT (K772330)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-01-12
RIA FOR SERUM THYROXINE (K771415)Clinical Immuno-Diagnostics1978-01-05
EMIT CENTRIFICHEM THYROXINE ASSAY (K772170)Syva Co.1977-12-22
PEDIATRIC THYROXINE TEST SYS. T4 (K771609)Corning Medical & Scientific1977-12-20
IN VITRO DIAGNOSTIC REAGENT (K772096)Pcl-Ria, Inc.1977-11-22
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