Atlas FDA

KHQ

93 FDA 510(k) clearances · Product code

41 daysmedian time to decision
104 days90th percentile
93clearances measured

FDA profile

Official device name
Radioassay, Triiodothyronine Uptake
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1715
Medical specialty
Clinical Chemistry
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RecordFirmDate
ACE T UPTAKE REAGENT TU CALIBRATORS (K981375)Schiapparelli Biosystems, Inc.1998-06-10
T-UPTAKE MICROPLATE EIA (K980088)Monobind1998-02-04
CHIRON DIAGNOSTICS ACS:180TU P (K970539)Chiron Diagnostics Corp.1997-03-24
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) (K964308)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
ELECSYS T-UPTAKE ASSAY (K961488)Boehringer Mannheim Corp.1996-06-12
CEDIA T UPTAKE ASSAY (K954807)Boehringer Mannheim Corp.1995-12-21
T-UPTAKE EIA TEST (K951586)Diagnostic Reagents, Inc.1995-05-15
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (K933414)Baxter Diagnostics, Inc.1994-11-22
AXSYM(TM) T-UPTAKE (K934312)Abbott Laboratories1994-06-21
VIDAS T UPTAKE (K935816)Biomerieux Vitek, Inc.1994-03-22
T3 UPTAKE CHEMILUMINESCENCE ASSAY (K926220)Nichols Institute Diagnostics1993-11-17
IQ TUPTAKE ASSAY (K931294)Becton Dickinson Advanced Diagnostics1993-07-22
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS (K926443)Roche Diagnostic Systems, Inc.1993-05-20
CIBA CORNING ACS T UPTAKE IMMUNOASSAY (K925257)Ciba Corning Diagnostics Corp.1992-12-28
VISTA THYROXINE UPTAKE ASSAY (K923676)Syva Co.1992-10-09
AIA-PACK T-U (K913663)Tosoh Corp.1991-09-30
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (K911912)Serono-Baker Diagnostics, Inc.1991-09-18
CIBA CORNING ACS T UPTAKE IMMUNOASSAY (K911093)Ciba Corning Diagnostics Corp.1991-04-29
IL T UPTAKE ASSAY SYSTEM (K903396)Instrumentation Laboratory CO1990-10-12
SEROZYME FREE T3 IMMUNOASSAY (K902748)Advanced Magnetics, Inc.1990-08-09
OPUS TM T-UPTAKE TEST SYSTEM (K902797)Pb Diagnostic Systems, Inc.1990-07-30
T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT (K896925)In Vitro Diagnostics, Inc.1990-01-18
FIAGEN T3 UPTAKE CATALOGUE #101-402 (K895186)Cyberfluor, Inc.1989-11-08
EMIT T-UPTAKE ASSAY (K894145)Syva Co.1989-09-05
D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN (K892224)Photec Diagnostics, Inc.1989-06-16
VENTREX COATED TUBE T3 UPTAKE (K891068)Ventrex Laboratories, Inc.1989-04-10
ACA THYRONINE UPTAKE (TU E) METHOD (K885259)The DU Pont Co.1989-02-17
TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE (K883765)Biotecx Laboratories, Inc.1988-10-31
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (K883085)Serono Diagnostics, Inc.1988-09-09
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY (K881855)Syva Co.1988-06-10
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO (K880619)Syva Co.1988-04-18
AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 (K874362)Amersham Corp.1988-02-18
CEDIA(TM) T UPTAKE (K872447)Microgenics Corp.1987-08-21
IMMUBEAD THYROID UPTAKE (K872172)Immunotech Corp.1987-08-17
AFFINITY(TM) I UPTAKE IMMUNIT(TM) (K865083)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-07-09
CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY (K864132)Ciba Corning Diagnostics Corp.1986-12-16
PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT (K862447)Pantex, Div. Bio-Analysis, Inc.1986-10-07
FREE T3 RADIOIMMUNOASSAY KIT (K862968)Bioclinical Group1986-09-25
MMS T3 UPTAKE (K861262)Micromedic Systems1986-05-23
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY (K860422)American Dade1986-04-11
T3 UPTAKE RADIOIMMUNOASSAY KIT (K855169)Cambridge Medical Technology1986-02-06
T-3 UPTAKE/RIASSAY (K855033)Ria Diagnostics1986-01-24
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT (K842694)Terumo Medical Corp.1984-09-07
T3 UPTAKE (K841927)Syncor Intl. Corp.1984-06-25
IMMPULSE TBC ASSAY REAGENTS (K840853)Paragon Diagnostics, Inc.1984-04-01
TRI-TUBE RIA (K840589)Nuclear Medical Laboratories, Inc.1984-03-09
STRATUS THYROID UPTAKE FLUOROMETRIC (K834209)American Dade1984-03-09
ACA THYROXINE UPTAKE ANALYTICAL TEST (K833703)E.I. Dupont DE Nemours & Co., Inc.1984-01-30
MAGIC TM 125I T3 UPTAKE RADIOASSAY (K831613)Corning Medical & Scientific1983-08-11
UPTAKE T3 RADIOIMMUNOASSAY KIT (K830900)Medical & Scientific Designs, Inc.1983-04-18
TDX T-UPTAKE (K830912)Abbott Laboratories1983-04-12
ADVANCE TM T-3 UPTAKE ASSAY (K822592)Syva Co.1982-10-08
LEECO T3% DIAGNOSTIC KIT (K822575)Leeco Diagnostics, Inc.1982-09-30
T3 UPTAKE KITS (K822612)Pcl-Ria, Inc.1982-09-30
ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT (K821553)Amf Biological and Diagnostics Co.1982-06-25
T3 UPTAKE DIAGNOSTIC KIT (K821722)Diagnostic Reagents, Inc.1982-06-24
ENZYME-TEST TBC T4 UPTAKE (K820879)Icl Scientific1982-04-16
T3 UPTAKE-SQUIBB DIAGNOSTIC KIT (K820340)E. R. Squibb & Sons, Inc.1982-03-04
T3 UPTAKE KIT (K810857)Immuno Assay Corp.1981-04-08
COAT-A-COUNT T3 UPTAKE KIT (K810717)Diagnostic Products Corp.1981-03-31
DAC-CEL T3 UPTAKE (K810212)Burroughs Wellcome Co.1981-02-10
IMMU-TRACE T3 UPTAKE (T3U) REAGENTS (K803044)American Dade1981-01-02
OREAI-Q-TU TEST (K802464)Organon, Inc.1980-10-31
T3 UPTAKE TEST SYSTEM (K802468)American Diagnostic Corp.1980-10-31
ANALYTE T3 UPTAKE (K802246)Technicon Instruments Corp.1980-10-23
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY (K800911)Abbott Laboratories1980-06-20
VENTRE/SEP T3 UPTAKE RADIOASSAY (K800165)Ventrex Laboratories, Inc.1980-02-13
EMC-M-180, T3 UPTAKE - 100 TUBES (K800188)Endocrine-Metabolic Center1980-02-13
AMES RIALYZE - UPTAKE CHROM. TUBES (K800170)Miles Laboratories, Inc.1980-02-13
AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM (K792662)Micromedic Systems1980-01-17
T3 UPTAKE (T3U) REAGENTS (K792607)Dade, Baxter Travenol Diagnostics, Inc.1980-01-16
TIPSEP-T3U TRIIODOTHYRONINE UPTAKE (K792484)Nuclear Diagnostics, Inc.1979-12-27
IMMUCHEM COVALENT COAT BINDING (K791662)Immuchem Corp.1979-09-27
T3 UPTAKE RADIOIMMUNOASSAY KIT (K791361)Technia Diagnostics , Ltd.1979-08-16
T-3 UPTAKE (MAA) KIT (K790461)Amersham Corp.1979-05-03
T3 UPTAKE KIT (K790417)E. R. Squibb & Sons, Inc.1979-04-20
RIA KIT, QUANTITOPE T3 UPTAKE (K781905)Kallestad Laboratories, Inc.1979-01-03
RIA, T3 UPTAKE SOLID PHASE (K781662)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-11-08
ORTHO*T-3 UPTAKE KIT (K781482)Ortho Diagnostics, Inc.1978-09-27
CLINIRIA T-3 UPTAKE TEST (K781180)Miles Laboratories, Inc.1978-08-14
T-3 UPTAKE (SORBENT) KIT (K780525)Amersham Corp.1978-05-19
CBR-T3 UPTAKE KIT (K780500)Clinical Bioresearch1978-05-03
REAGENT SYSTEM, ARIA II T3 UPTAKE (K780253)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-03-28
T3 UPTAKE TEST (K780361)Monobind1978-03-22
T3 STI KIT (K780146)Polysciences, Inc.1978-02-23
SPINSEP-T3 (K771854)Nuclear Diagnostics, Inc.1977-12-22
AMES T-3 UPTAKE STRIP TEST (K772088)Miles Laboratories, Inc.1977-12-06
PHADEBAS T3 U TEST (K771078)Pharmacia, Inc.1977-06-27
T3 UPTAKE REAGENT SET (K770845)The Dow Chemical Co.1977-05-26
IN VITRO T-3 UPTAKE TEST (K770480)Clinical Assays, Inc.1977-04-06
DATA-TOPE T3 UPTAKE PROCEDURE (K761281)Dade, Baxter Travenol Diagnostics, Inc.1977-02-09
SPAC TM T3 UPTAKE KIT (K770033)Mallinckrodt Critical Care1977-02-07
T-3 UPTAKE KIT (K760802)Diagnostic Products Corp.1976-10-29

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