Atlas FDA

CDP

144 FDA 510(k) clearances · Product code

50 daysmedian time to decision
122 days90th percentile
144clearances measured

FDA profile

Official device name
Radioimmunoassay, Total Triiodothyronine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1710
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2021: 120 · 2022: 123 · 2023: 131 · 2024: 41 · 2025: 25 · 2026: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (K001607)Repromedix Corp.2000-10-05
CHIRON DIAGNOSTICS ACS: 180 FT3 (K991692)Chiron Diagnostics Corp.1999-06-18
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (K991311)Biocheck, Inc.1999-06-02
AIA-PACK FT3 ASSAY (K991252)Tosoh Medics, Inc.1999-05-11
OPTICOAT T3 EIA KIT (K981824)Biotecx Laboratories, Inc.1998-12-22
ABBOTT ARCHITECT FREE T3 (K983439)Abbott Laboratories1998-11-20
ABBOTT ARCHITECT TOTAL T3 (K983434)Abbott Laboratories1998-11-20
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (K974027)Alfa Biotech (Uk) , Ltd.1998-02-02
IMMULITE FREE T3 (K974634)Diagnostic Products Corp.1998-01-02
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973966)Beckman Instruments, Inc.1997-10-31
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (K971779)Monobind1997-06-16
DSL ACTIVE T3 EIA (K971270)Diagnostic Systems Laboratories, Inc.1997-05-22
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT (K965058)Nichols Institute Diagnostics1997-03-11
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) (K970016)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-30
ELECSYS FT3 (K963127)Boehringer Mannheim Corp.1996-12-16
ENZYMUN-TEST FT3 (K962760)Boehringer Mannheim Corp.1996-11-29
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) (K964310)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
AIA-PACK FT3 ASSAY (K963687)Tosoh Medics, Inc.1996-11-08
IMX FREE TRIIODOTHYRONINE (FREE T3) (K963833)Abbott Laboratories1996-10-30
AXSYM FREE TRIIODOTHYRONINE (FREE T3) (K963827)Abbott Laboratories1996-10-30
ELECSYS T3 (K962508)Boehringer Mannheim Corp.1996-08-15
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962355)Bayer Corp.1996-07-12
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE (K961236)United Biotech, Inc.1996-05-30
ACCESS FREE T3 ASSAY (K960913)Bio-Rad Laboratories, Inc.1996-03-29
T-3 MICROWELL EIA MODEL 7013 (K960412)Biomerica, Inc.1996-03-19
ACTIVE T3 RIA (K960550)Diagnostic Systems Laboratories, Inc.1996-03-06
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS (K952557)Sigma Diagnostics, Inc.1996-01-24
ACCESS TOTAL T3 ASSAY (MODIFICATION) (K955435)Bio-Rad Laboratories, Inc.1996-01-24
OPUS T3 (K953160)Behring Diagnostics, Inc.1995-08-24
IMX T3 ASSAY (K944808)Organon Teknika Corp.1994-12-09
ACCESS(R) TOTAL T3 (K940833)Bio-Rad Laboratories, Inc.1994-09-07
AIA-PACK TT3 ASSAY (K936229)Tosoh Medics, Inc.1994-07-14
AXSYM TOTAL T3 (K934517)Abbott Laboratories1994-06-21
VIDAS T3 ASSAY (K934764)Biomerieux Vitek, Inc.1994-03-22
CIBA CORNING ACS FREE T3 IMMUNOASSAY (K932747)Ciba Corning Diagnostics Corp.1993-12-03
COBAS(R) CORE T3 EIA (K932608)Roche Diagnostic Systems, Inc.1993-12-03
CHEMILUMINESCENCE FREE T3 IMMUNOASSAY (K931600)Nichols Institute1993-09-08
TRIODOTHYRONINE (TC) COATED TUBE RIA (K926345)Monobind1993-02-25
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT (K925436)Medix Biotech, Inc.1992-12-28
VISTA TRIIODOTHYRONINE ASSAY (K923571)Syva Co.1992-10-15
KODAK AMERLEX MAB FT3 ASSAY (K922771)Eastman Kodak Company1992-10-14
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE (K923258)Heraeus Kulzer, Inc.1992-09-23
TOTAL T3 CHEMILUMINESCENCE ASSAY (K923015)Nichols Institute Diagnostics1992-09-02
MILENIA TOTAL T3 (K914467)Diagnostic Products Corp.1992-02-06
DOCUMENT CK ISOENZYMES CONTROL (K915792)Casco Standards1992-02-06
SRI T3 IMMOENZYMETRIC ASSAY (K910737)Serono-Baker Diagnostics, Inc.1991-05-01
OPUS T3 TEST SYSTEM (K905410)Pb Diagnostic Systems, Inc.1991-02-04
IMMULITE (TM) TOTAL T3 (K905214)Cirrus Diagnostics, Inc.1991-02-01
FLAGEN TRIIODOTHYRONINE (T3) ASSAY (K905656)Cyberfluor, Inc.1991-01-23
IMX FREE TRIIODOTHYRONINE (K905261)Abbott Laboratories1991-01-23
MICROZYME T3 ENZYME IMMUNOASSAY KIT (K904820)Immunotech Corp.1990-12-18
TDX FREE T3 CALCULATION (K903433)Abbott Laboratories1990-10-12
CEDIA TOTAL T3 ASSAY (K904098)Microgenics Corp.1990-09-27
IMX FREE T3 CALCULATION (K903432)Abbott Laboratories1990-09-07
TOSOH AIA-PACK T3 (K897001)Tosoh Corp.1990-03-09
ENZYMUN TEST R T3 (K896900)Boehringer Mannheim Corp.1990-02-08
ABBOTT TDX TOTAL T3 PLUS (K894238)Abbott Laboratories1989-10-31
MILENIA(TM) TOTAL T4 (MKT41,5) (K895840)Diagnostic Products Corp.1989-10-19
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. (K894993)Baxter Healthcare Corp1989-10-13
FREE T3 RADIOIMMUNOASSAY KIT (K894200)Advanced Magnetics, Inc.1989-09-25
T3 CLASP-BEAD EIA KIT (K893620)Biotecx Laboratories, Inc.1989-08-11
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT (K885195)Amersham Corp.1989-02-08
DELFIA TRIIODOTHYRONINE (T3) KIT (K883810)Pharmacia, Inc.1988-12-02
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME (K883479)Baxter Healthcare Corp1988-10-25
IMMPULSE T, ASSAY REAGENTS (K881214)Sclavo, Inc.1988-05-27
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT (K881373)Amersham Corp.1988-05-27
ABBOTT IMX T3 (K880087)Abbott Laboratories1988-04-18
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE (K880388)Serono Diagnostics, Inc.1988-03-03
NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY (K873737)Cambridge Medical Technology1987-11-24
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY (K873945)Ciba Corning Diagnostics Corp.1987-11-23
AMERLITE TT3 ASSAY, LAN.0003/1003/2003 (K873858)Amersham Corp.1987-11-03
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT (K872191)Immunotech Corp.1987-08-13
TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (K870968)Canadian Bioclinical, Ltd.1987-06-22
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT (K864452)Lkb Instruments, Inc.1987-02-02
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA (K860252)Amersham Corp.1986-02-11
VENTREZYME T3 IMMUNOASSAY T3 (K853703)Vxr, Inc.1985-10-04
T-3 RIASSAY (K852537)Ria Diagnostics1985-08-12
TDX TOTAL T3 (K851676)Abbott Laboratories1985-05-20
AMERLEX-M FREE T-3 RIA (K842949)Amersham Corp.1984-09-05
AMER. BIO-SCIENCE LAB T3 REAGENTS (K842590)American Bio-Science Laboratories1984-08-10
CORNING IMMO PHASE FREE T3 (K840222)Corning Medical & Scientific1984-05-07
FREE T3 SOLID PHASE RADIOIMMUNOASSAY (K840959)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-04-18
SOPHEIA T3 EIA KIT (K840050)Diagnostic Products Corp.1984-03-19
LEECO T3-QUANT DIAG. KIT (K834348)Leeco Diagnostics, Inc.1984-02-21
T3 RIA (K833853)Syncor Intl. Corp.1984-02-04
ENDAB T3 (K834049)Immunotech Corp.1984-01-30
COAT-A-COUNT FREE T3 RIA KIT (K832164)Diagnostic Products Corp.1983-10-27
T3-RIA SINGLE REAGENT (K832469)Fairlake Laboratories1983-09-12
CORNING'S MAGIC T3(125I) RADIOIMMUNO- (K832353)Corning Medical & Scientific1983-08-31
ISO-SEP SYSTEM (K831434)Berwick Medical Products, Inc.1983-06-30
AMERLEX FREE T-3 RIA KIT (K830980)Amersham Corp.1983-05-25
PHASE II T3 RADIOIMMUNOASSAY KIT (K831064)Medical & Scientific Designs, Inc.1983-05-09
LEECO T3-RIA DIAGNOSTIC KIT (K830808)Leeco Diagnostics, Inc.1983-04-08
T3 DIAGNOSTIC KIT RIA (K821725)Diagnostic Reagents, Inc.1982-06-24
T4 DIAGNOSTIC KIT (K820251)Diagnostic Reagents, Inc.1982-05-05
ENZYM-LINKED T3 (K820763)Icl Scientific1982-04-15
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO (K812611)Kallestad Laboratories, Inc.1981-10-02
THYROXINE (T4) 125I (K812666)Pcl-Ria, Inc.1981-10-02
COAT-A-COUNT T3 RIA KIT (K812246)Diagnostic Products Corp.1981-08-20
T3 (RIA) KIT (K811213)Immuno Assay Corp.1981-05-29
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