Atlas FDA

CEC

92 FDA 510(k) clearances · Product code

71 daysmedian time to decision
238 days90th percentile
92clearances measured

FDA profile

Official device name
Radioimmunoassay, Free Thyroxine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1695
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 96 · 2022: 81 · 2023: 99 · 2024: 276 · 2025: 213 · 2026: 97
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access Free T4 (K240273)Beckman Coulter, Inc.2024-03-06
Elecsys FT4 IV (K220456)Roche Diagnostics2023-04-07
MAGLUMI 2000 FT4 (K182423)Shenzhen New Industries Biomedical Engineering Co., Ltd.2018-10-04
Elecsys FT4 III (K181233)Roche Diagnostics2018-09-18
Abbott Architect Free T4 (K173122)Abbott Laboratories2017-10-27
FREND™ Free T4 Test System (K152422)Nanoentek USA, Inc.2016-02-17
VIDAS FT4 (K132058)Biomerieux S.A.2015-06-08
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT (K140859)Siemens Healthcare Diagnostics, Inc.2014-11-26
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART (K140842)Siemens Healthcare Diagnostics, Inc.2014-11-26
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (K131244)Roche Diagnostics2014-01-27
ADVIA CENTAUR FT4, ADVIA CENTAUR T4 (K132249)Siemens Healthcare Diagnostics, Inc.2013-09-13
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 (K121951)DiaSorin, Inc.2013-04-04
ABBOTT ARCHITECT FREE T4 (K123379)Abbott Laboratories2012-11-27
IMMULITE 2000 FREE T4 (K083373)Siemens Healthcare Diagnostics, Inc.2009-02-02
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS (K080167)Siemens Healthcare Diagnostics2008-08-08
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD (K073604)Dade Behring, Inc.2008-03-13
OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 (K070708)Olympus Life & Material Science Europa GmbH (Irish2007-08-21
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR (K053531)Dade Behring, Inc.2006-03-03
FASTPACK FREE T4 IMMUNOASSAY (K030329)Qualigen, Inc.2003-07-03
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 (K020548)Monobind2002-04-05
ABBOTT ARCHITECT FREE T4 (K983417)Abbott Laboratories1998-11-20
FREE T4 MICROWELL EIA, MODEL #7019 (K982954)Biomerica, Inc.1998-09-24
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K982250)Beckman Instruments, Inc.1998-07-14
BIOSTRIDE FREE T4 EIA TEST KIT (K981243)Biostride Diagnostics, Inc.1998-06-29
BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS (K980819)Biocircuits Corp.1998-04-03
SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY (K974551)Sealite Sciences, Inc.1997-12-22
IMMULITE FREE T4 (2-STEP) (K971792)Diagnostic Products Corp.1997-07-25
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (K971141)Dade Chemistry Systems, Inc.1997-04-28
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT (K962408)Nichols Institute Diagnostics1997-03-18
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) (K965142)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
ACA PLUS FREE THYROXINE(FT4) METHOD (K962602)Dade Intl., Inc.1996-08-15
ELECSYS FT4 ASSAY (K961489)Boehringer Mannheim Corp.1996-06-11
AMERLITE MAB FT4 ASSAY (K955097)Kodak Clinical Diagnostics, Ltd.1995-12-20
COBAS CORE FREE T3 EIA (K942376)Roche Diagnostic Systems, Inc.1995-04-21
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK (K944697)Organon Teknika Corp.1995-02-22
OPUS FT4 TEST SYSTEM (K940507)Pb Diagnostic Systems, Inc.1994-07-28
AXSYM FREE THYROXINE ( FREE T4 ) (K934544)Abbott Laboratories1994-06-21
CIBA CORNING ACS FT3 IMMUNOASSAY (K940482)Ciba Corning Diagnostics Corp.1994-04-26
COBAS(R) CORE FT4 EIA (K932607)Roche Diagnostic Systems, Inc.1994-01-24
FT4 RADIOIMMUNOASSAY (K934012)Immunotech S.A.1993-11-16
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) (K930322)Heraeus Kulzer, Inc.1993-11-10
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC (K932912)Baxter Diagnostics, Inc.1993-10-28
IMMULITE FREE T4 (K931704)Diagnostic Products Corp.1993-08-16
RADIAS FREE T4 ENZYME IMMUNOASSAY (K931110)Bio-Rad1993-05-20
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM (K925842)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-04-20
NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY (K925649)Solarcare Technologies Corp,Inc.1993-03-01
ACCESS(R) FREE T4 ASSAY (K925913)Bio-Rad Laboratories, Inc.1993-01-27
VIDAS FREE THYROXINE(FT4) ASSAY (K925177)Biomerieux Vitek, Inc.1992-11-30
VISTA FREE THYROXINE ASSAY (K923572)Syva Co.1992-11-16
KODAK AMERLITE MAB FT3 ASSAY (K922713)Eastman Kodak Company1992-10-26
ELEGANCE FT4 ELISA (K922284)Bioclone Australia Pty , Ltd.1992-07-10
AMERLITE MAB FT4 ASSAY (K920247)Eastman Kodak Company1992-03-02
LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY (K914835)London Diagnostics, Inc.1991-12-17
SR1 FREE T4 ENZYME IMMUNOASSAY (K912937)Serono-Baker Diagnostics, Inc.1991-11-19
AFFINITY FREE T4 TEST SYSTEM (K912698)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-07
AIA-PACK FT4 (K913493)Tosoh Corp.1991-09-10
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST (K911634)Immunotech Corp.1991-06-24
CIBA CORNING ACS FT4 IMMUNOASSAY (K910684)Ciba Corning Diagnostics Corp.1991-05-01
FLAGEN TM FREE T4 (K904539)Cyberfluor, Inc.1990-11-30
TDX FREE T4 CALCULATION (K903383)Abbott Laboratories1990-09-10
IMX FREE T4 CALCULATION (K903384)Abbott Laboratories1990-09-10
ABBOTT IMX FREE T4 (K902834)Abbott Laboratories1990-09-07
ENZYMUN TEST(R) FT4 (FREE THYROXINE) (K900883)Boehringer Mannheim Corp.1990-05-15
FREE T4 IMMUNOASSAY KIT (K900060)Advanced Magnetics, Inc.1990-03-29
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT (K896222)Nichols Institute Diagnostics1989-11-17
DELFIA FREE THYROXINE (FT4) KIT (K894605)Pharmacia, Inc.1989-09-18
AMERLEX-MAB FT4 KIT (K894091)Amersham Corp.1989-08-03
MODIFIED FREE T4 RADIOIMMUNOASSAY KIT (K884753)Advanced Magnetics, Inc.1989-02-27
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT (K883123)Amersham Corp.1988-12-22
QLIA T UPTAKE ASSAY (K883971)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-25
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) (K874875)Boots-Celltech Diagnostics, Inc.1988-03-24
DIAGNOSTIC KIT FREE T3 AND FREE T4 (K870268)Sclavo, Inc.1987-09-14
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. (K870158)American Dade1987-03-19
IQ FTI IMMUNOASSAY (K865104)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-16
IQ FREE T4 IMMUNOASSAY (K864658)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
SIMULTRAC FREE T4[57CO]/TSH MAB[125I] (K864838)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-02-18
AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA (K860251)Amersham Corp.1986-02-11
SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY (K853628)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-09-18
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT (K842482)Amersham Corp.1984-08-10
PHASE II FREE T4 KIT (K840901)Medical & Scientific Designs, Inc.1984-04-25
CORNING MAGIC SINGLE STEP FREE T4 (K832381)Corning Medical & Scientific1983-09-01
THYROXINE ANALYSIS PRODUCTS/RADIO-FREE (K823264)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-01-12
BIO MAG FREE T4 RADIOIMMUNOASSAY KIT (K823005)Bioclinical Group1982-12-15
SINGLE STEP FREE-T4 125I RADIOIMMUNO- (K823144)Corning Medical & Scientific1982-11-29
COAT-A-COUNT FREE THYROXINE KIT/COMPONEN (K822882)Diagnostic Products Corp.1982-11-05
FREE T4 RADIOIMMUNOASSAY KIT (K821241)Bioclinical Group1982-06-01
FREE T4 RIA TEST SET (K813465)Ventrex Laboratories, Inc.1981-12-31
CODE IM 2050 AMERLEX FREE T4 RIA KIT (K810231)Amersham Corp.1981-02-10
RIA DIAG. TEST KIT FOR INDEXING THYROX. (K781560)Nuclear Diagnostics, Inc.1978-10-17
RIA TEST KIT SYS. DAMON KIQUISOL FREE (K781012)Damon Corp.1978-07-27
IMMO PHASE FT4 ASSAY (K772194)Corning Medical & Scientific1978-01-06
TRIOBEAD-125 DIAGNOSTIC KIT (K771236)Abbott Laboratories1977-08-03

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Every clearance here is in the API, with alerts when new ones post.