Atlas FDA

KLI

86 FDA 510(k) clearances · Product code

58 daysmedian time to decision
155 days90th percentile
86clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1700
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2011: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VITROS® Automation Solutions (K160495)Ortho-Clinical Diagnostics, Inc.2016-10-18
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (K131515)Alfa Wassermann2013-08-14
GSP NEONATAL THYROXINE (T4) (K103484)Wallac Oy, A Subsidiary of Perkinelmer, Inc.2011-04-22
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (K082638)Siemens Healthcare Diagnostics, Inc.2009-02-26
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (K030860)Monobind2003-08-22
ACCESS TOTAL T4 ASSAY (K023369)Beckman Coulter, Inc.2002-12-09
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (K001603)Repromedix Corp.2000-10-05
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (K000600)Syva Co., Dade Behring, Inc.2000-03-27
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (K991432)Biocheck, Inc.1999-06-02
OPTICOAT T4 EIA KIT (K982298)Biotecx Laboratories, Inc.1999-02-03
ABBOTT ARCHITECT TOTAL T4 (K983440)Abbott Laboratories1998-11-25
ACE T4 REAGENT T4 CALIBRATORS (K981377)Schiapparelli Biosystems, Inc.1998-06-10
ACCUWELL T4-EIA (K972974)Neometrics, Inc.1997-10-06
TOTAL THROXINE MICROPLATE EIA(225-300) (K971709)Monobind1997-06-16
DSL ACTIVE T4 EIA (K971269)Diagnostic Systems Laboratories, Inc.1997-05-22
SYNCHRON SYSTEMS THYROXINE REAGENT (K971203)Beckman Instruments, Inc.1997-05-16
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) (K964721)Johnson & Johnson Clinical Diagnostics, Inc.1996-12-18
ISOLAB'S T4 TEST KIT (K951014)Isolab, Inc.1996-10-18
UBI MAGIWEL THYROXINE (T4) QUANTITATIVE (K962211)United Biotech, Inc.1996-07-08
BIOCIRCUITS IOS T4/TU TEST CARTRIDGES (K952751)Biocircuits Corp.1995-11-20
BIOCIRCUITS IOS T4 TEST CARTRIDGE (K953837)Biocircuits Corp.1995-11-20
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY (K951321)Bio-Rad1995-08-24
T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 (K950588)Biomerica, Inc.1995-06-29
RADIAS TOTAL T4 ENZYME IMMUNOASSAY (K946163)Bio-Rad1995-02-22
THYROXINE ENZYME IMMUNOASSAY (K944703)Diagnostic Reagents, Inc.1994-12-09
CEDIA T4 MAB ASSAY (K943019)Microgenics Corp.1994-10-20
CEDIA T4 MAB ASSAY (K942575)Microgenics Corp.1994-07-28
CEDIA T4 MAB ASSAY (K941042)Microgenics Corp.1994-04-26
CEDIA T4 MAB ASSAY MODIFICATION (K935880)Microgenics Corp.1994-03-03
COBAS (R) CORE T4 EIA (K932605)Roche Diagnostic Systems, Inc.1994-01-24
ACCESS(R) THYROXINE ASSAY (K926475)Bio-Rad Laboratories, Inc.1993-06-15
VIDAS THYROXINE (T4) ASSAY (T4) (K926393)Biomerieux Vitek, Inc.1993-05-13
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION (K922433)Syva Co.1992-09-18
THYROXINE (FPIA) KIT (K921904)Tudor Laboratories, Inc.1992-06-24
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT (K920712)Medix Biotech, Inc.1992-03-27
CEDIA T4 (K915194)Boehringer Mannheim Corp.1991-12-09
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES (K912616)Technicon Instruments Corp.1991-09-25
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (K911217)Serono-Baker Diagnostics, Inc.1991-08-16
IMMULITE(TM) TOTAL T4 (K910261)Cirrus Diagnostics, Inc.1991-04-16
IL THYROXINE (T4) ASSAY SYSTEM (K903095)Instrumentation Laboratory CO1990-08-23
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR (K897072)Kallestad Diag, A Div. of Erbamont, Inc.1990-03-29
OPUS T4 TEST SYSTEM (K897193)Pb Diagnostic Systems, Inc.1990-03-19
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT (K897144)Medix Biotech, Inc.1990-03-15
AIA-PACK T4 (K896982)Tosoh Corp.1990-03-09
VITRO T4-EIA-XT (K896865)In Vitro Diagnostics, Inc.1990-01-30
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. (K896329)Photec Diagnostics, Inc.1989-12-12
T4 CLASP-BEAD EIA KIT (K892853)Biotecx Laboratories, Inc.1989-05-22
EMIT CONVENIENCE PACK: THYROXINE ASSAY (K890831)Syva Co.1989-04-14
THYROXINE MICROASSAY (K884260)Diamedix Corp.1989-02-23
ACA THYROXINE (T4 E) METHOD (K885258)The DU Pont Co.1989-02-17
EMIT THYROXINE ASSAY (K885141)Syva Co.1989-02-17
ANALYST THYROXINE (T4) ROTOR (K884700)The DU Pont Co.1989-01-27
MODIFIED CEDIA TOTAL T4 ASSAY (K884634)Microgenics Corp.1988-12-09
EMIT CONVENIENCE PACK: THYROXINE ASSAY (K881357)Syva Co.1988-05-27
EMIT THYROXINE ASSAY (K880620)Syva Co.1988-03-24
VISION(R) THYROXINE (T4) (K880662)Abbott Laboratories1988-03-16
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (K874866)Serono Diagnostics, Inc.1988-02-11
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY) (K874603)Ciba Corning Diagnostics Corp.1987-12-18
AMERLITE TT4 ASSAY (240/480/144 TEST KITS) (K873976)Amersham Corp.1987-11-05
AFFINITY TOTAL THYROXINE IMMUNIT (K873518)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-10-29
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT (K872192)Immunotech Corp.1987-08-13
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME) (K862233)Ciba Corning Diagnostics Corp.1986-10-14
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT (K854971)V-Tech, Inc.1986-02-06
CEDIA TOTAL T4 ASSAY (K852164)Microgenics Corp.1985-07-22
TERUMO SENSIBEAD THYROXINE EIA KIT (K841601)Terumo Medical Corp.1984-05-22
TECHNICON RA-1000 SYS T4-THYROXINE (K841576)Technicon Instruments Corp.1984-05-22
VENTREZYME T4 IMMUNOASSAY T4 (K840473)Vxr, Inc.1984-04-04
THYROXINE EMIA (K840241)Collaborative Research, Inc.1984-03-30
RA-1000 SYS-T4(THYROXINE)SERUM ANAL (K834102)Technicon Instruments Corp.1984-03-15
STRATUS TOTAL THYROXINE FLUOROMETRIC (K834210)American Dade1984-03-05
TDX THYROXINE (K830683)Abbott Laboratories1983-04-06
FEKAL CON-TRATE SYSTEM (K830769)Trend Scientific, Inc.1983-04-05
PARAMOUNT THYROXINE ASSAY (K830136)Syva Co.1983-02-07
SOPHEIA THYROXINE EIA KIT (K823751)Diagnostic Products Corp.1983-01-12
SYVA ADVANCE THYROXINE ASSAY (K823034)Syva Co.1982-11-08
ENZYMUNE-TEST T4 (K820750)Icl Scientific1982-04-06
EMIT-TFG PRISMA THYROXINE ASSAY (K810586)Syva Co.1981-03-17
OREIA-Q-TY, ENZYME IMMUNOASSAY (K802693)Organon, Inc.1980-12-10
APPLICATION OF EMIT AED ASSAYS (K801475)Syva Co.1980-07-08
EMIT AAII THYROXINE ASSAY (K801288)Syva Co.1980-06-30
SMAC SYSTEM, T4 METHOD (K800384)Technicon Instruments Corp.1980-03-19
A-GENT QUANTICHROM T4 11A (K790848)Abbott Laboratories1979-08-10
EMIT CFA THYROXINE ASSAY (K790686)Syva Co.1979-05-25
EMIT THYROXINE ASSAY (K782085)Syva Co.1979-02-01
COMPUTER, 3500, GILFORD SYSTEM (K781828)Syva Co.1978-12-04
ENIT ABA THYROXINE ASSAY (K770070)Syva Co.1977-01-21

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