Atlas FDA

DBF

87 FDA 510(k) clearances · Product code

44 daysmedian time to decision
126 days90th percentile
87clearances measured

FDA profile

Official device name
Ferritin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5340
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LIAISON Ferritin (K193650)DiaSorin, Inc.2021-09-14
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (K191562)HORIBA ABX SAS2020-03-06
Atellica IM Ferritin Assay (K171642)Siemens Healthcare Diagnostics, Inc.2017-08-31
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET (K133083)Diazyme Laboratories2014-06-24
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (K121232)Kamiya Biomedical Company2012-05-24
ADVIA CHEMISTRY FERRITIN (FRT) METHOD (K110736)Siemens Healthcare Diagnostics, Inc.2011-08-17
TINA-QUANT FERRITIN GEN. 4 (K100538)Roche Diagnostics2010-06-22
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (K092505)Beckman Coulter, Inc.2009-12-11
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (K062746)Medicon Hellas S.A2006-11-20
RDI HSFERRITIN KIT (K053211)Reference Diagnostics, Inc.2006-03-13
FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, (K052617)Good Biotech Corp.2006-02-23
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (K050944)Kamiya Biomedical Co.2005-12-23
QUANTEX FERRITIN (K040879)Instrumentation Laboratory CO2004-05-10
FERRITIN GENERATION 2 (K031650)Roche Diagnostics Corp.2003-07-17
OLYMPUS FERRITIN REAGENT (K030124)Olympus America, Inc.2003-02-06
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET (K014293)Kamiya Biomedical Co.2002-02-19
RANDOX FERRITIN (K000662)Randox Laboratories, Ltd.2000-04-03
N LATEX FERRITIN (K993273)Dade Behring, Inc.1999-11-23
BIOCHECK FERRITIN ELISA MODEL BC-1025 (K992517)Biocheck, Inc.1999-09-24
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY (K992157)Chiron Diagnostics Corp.1999-08-05
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY (K984186)Nichols Institute Diagnostics1999-02-02
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR (K983340)Beckman Coulter, Inc.1998-12-14
ABBOTT ARCHITECT FERRITIN (K983759)Abbott Laboratories1998-12-07
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY (K982714)Bayer Corp.1998-10-22
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 (K974505)Alfa Biotech (Uk) , Ltd.1998-02-17
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) (K973331)Ortho-Clinical Diagnostics, Inc.1997-10-22
MODIFICATION OF OPUS FERRITIN TEST SYSTEM (K973202)Behring Diagnostics, Inc.1997-09-12
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY (K970612)Sealite Sciences, Inc.1997-06-24
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT (K963170)Olympus America, Inc.1996-12-02
UBI MAGIWEL FERRITIN QUANTITATIVE (K951993)United Biotech, Inc.1995-07-05
AMERLITE FERRITIN II ASSAY (K952286)Johnson & Johnson Clinical Diagnostics, Inc.1995-06-20
N LATEX FERRITIN (K950707)Behring Diagnostics, Inc.1995-03-27
AXSYM FERRITIN (K935847)Abbott Laboratories1994-06-21
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH (K935528)E.I. Dupont DE Nemours & Co., Inc.1994-01-28
VISTA FERRITIN ASSAY (K931576)Syva Co.1993-08-05
AIA-PACK FER CALIBRATION VERIFICATION TEST SET (K924858)Tosoh Medics, Inc.1992-12-15
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY (K920952)Vitek Systems, Inc.1992-04-07
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT (K920046)Medix Biotech, Inc.1992-01-28
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) (K911175)Serono-Baker Diagnostics, Inc.1991-04-05
CIBA CORNING ACS FERRITIN IMMUNOASSAY (K905770)Ciba Corning Diagnostics Corp.1991-03-12
ELEGANCE FERRITIN ELISA (K904822)Bioclone Australia Pty , Ltd.1990-11-29
LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. (K901075)London Diagnostics, Inc.1990-04-02
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT (K896585)Medix Biotech, Inc.1989-12-04
LAN.0800Q/2800Q (K895872)Amersham Corp.1989-10-17
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) (K892362)Amersham Corp.1989-05-09
AFFINITY(TM) FERRITIN IMMUNIT(TM) (K885074)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-01-04
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY (K884683)Serono-Baker Diagnostics, Inc.1988-12-27
MICROMEDIC FERRITIN IRMA KIT (K883746)Icn Micromedic Systems1988-10-27
AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 (K874203)Amersham Corp.1988-01-27
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM (K874572)Nichols Institute Diagnostics1987-12-02
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 (K874031)Diagnostic Products Corp.1987-11-25
CIBA CORNING MAGIC LITE FERRITIN (K873573)Ciba Corning Diagnostics Corp.1987-10-07
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM (K871489)Diagnostic Systems Laboratories, Inc.1987-06-12
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM (K870570)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS (K870107)Diagnostic Products Corp.1987-02-10
BECKMAN EPSILON(TM) FERRITIN TEST KIT (K864437)Beckman Instruments, Inc.1987-01-16
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY (K863345)Hybritech, Inc.1986-10-08
QUANTIMUNE(R) FERRITIN IRMA (K863487)Bio-Rad1986-10-01
PHASE II FERRITIN RADIOIMMUNOASSAY KIT (K862960)Medical & Scientific Designs, Inc.1986-08-27
IMMPULSE FERRITIN ASSAY REAGENT (K862014)Sclavo, Inc.1986-06-19
ENZYMUN-TEST FERRITIN (K860137)Boehringer Mannheim Corp.1986-03-28
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY (K844158)American Dade1984-11-19
DSL FERRITIN IRMA (K841925)Diagnostic Systems Laboratories, Inc.1984-05-25
DIAGNON FERRITIN 125 I RIA KIT (K830580)Iagnon Corp.1983-05-05
CORNING FERRITIN 125I RADIOIMMUNOASSAY (K830591)Corning Medical & Scientific1983-03-24
TANDEM-E -FER IMMUNOENZYMETRIC KIT (K823871)Hybritech, Inc.1983-02-25
AUTOPAK FERRITIN TEST DELIVERY SYS (K823275)Micromedic Systems1982-12-03
ANTISERA TO HUMAN FERRITIN (K822472)Kent Laboratories, Inc.1982-09-30
125I FERRITIN RADIOIMMUNOASSAY KIT (K812901)Bio-Ria1981-12-30
FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS (K812786)Corning Medical & Scientific1981-10-23
FERRITIN KIT (K812597)Hybritech, Inc.1981-10-19
SPECTRO FEIRITIN (K812056)Ramco Laboratories, Inc.1981-08-12
LEECO FERRITIN-QUANT DIAG. TEST KIT (K811880)Leeco Diagnostics, Inc.1981-07-16
FERRITIN RIA KIT (K811804)Amersham Corp.1981-07-10
AUTOPAK-12 FERRITIN KIT (K811808)Micromedic Systems1981-07-10
NORDICLAB FERRITIN IRMA TEST (K801989)Nordiclab Intl.1980-09-16
FERRIZYME FERRITIN ENZYME IMMUNOASSAY (K801676)Abbott Laboratories1980-08-20
FERRITIN RIA KIT (K801580)Diagnostic Products Corp.1980-08-13
FERRITIN CONTROLS CODE QAS.104 (K800657)Amersham Corp.1980-04-16
FERRITIN RIA KIT (K800299)Amersham Corp.1980-03-03
CENTRIA FERRITIN RIA (K792449)Union Carbide Corp.1979-12-31
FERRITIN RADIOIMMUNOASSAY (K792442)Dade, Baxter Travenol Diagnostics, Inc.1979-12-18
FERRITIN RIA KIT (K791860)Cis Radiopharmaceuticals, Inc.1979-12-06
VENTRE/SEP FERRITIN RIA (K790447)Ventrex Laboratories, Inc.1979-04-23
NEIA-FERRITIN ENZYMEIMMUNASSAY KIT (K790490)New England Immunology Assoc.1979-04-23
NEIA-FERRITIN ENZYMEIMMUNOASSAY (K780490)New England Immunology Assoc.1978-04-10
IN VITRO FERRITIN RIA TEST (K770702)Clinical Assays, Inc.1977-06-17

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