Atlas FDA

JMG

24 FDA 510(k) clearances · Product code

50 daysmedian time to decision
132 days90th percentile
24clearances measured

FDA profile

Official device name
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5340
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2006: 4 · 2013: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access Ferritin (K234052)Beckman Coulter, Inc.2024-03-20
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (K052082)Beckman Coulter, Inc.2005-08-19
TINA-QUANT FERRITIN ASSAY (K964282)Boehringer Mannheim Corp.1997-07-30
ELECSYS FERRITIN (K971833)Boehringer Mannheim Corp.1997-06-02
FERR FLEX REAGENT CARTRIDGE (K963498)Dade Chemistry Systems, Inc.1997-01-24
ACE(TM) CEDIA(R) FERRITIN ASSAY (K950393)Schiapparelli Biosystems, Inc.1995-05-16
ACCESS FERRITIN ASSAY (K926221)Bio-Rad Laboratories, Inc.1993-01-13
IMMULITE FERRITIN (K925848)Diagnostic Products Corp.1993-01-13
COBAS CORE FERRITIN EIA (K920829)Roche Diagnostic Systems, Inc.1992-06-19
CEDIA FERRITIN ASSAY (K920318)Microgenics Corp.1992-06-04
MILENIA (TM) FERRITIN (K902997)Diagnostic Products Corp.1990-08-02
RIA-GNOST FERRITIN (K890697)Cambridge Medical Technology1989-03-16
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. (K881138)Baxter Healthcare Corp1988-04-21
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT (K873730)Medix Biotech, Inc.1987-11-04
DELFIA(TM) FERRITIN KIT (K872955)Lkb Instruments, Inc.1987-08-21
CORNINGS MAGIC FERRITIN RADIOIMMUNO- (K840460)Corning Medical & Scientific1984-03-30
QUANTIMUNE FERRITIN IRMA (K810799)Bio-Rad1981-04-03
TERRITIN RIA KIT (K792588)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-01-11
RADIOIMMUNOASSAY TEST SYSTEM (K791096)Corning Medical & Scientific1979-08-03
IRMA TEST, NORDICLAB FERRITIN (K782157)Nordiclab Intl.1979-01-17
RIA KIT, FERRITIN SOLID PHASE (K781946)Bd Becton Dickinson Vacutainer Systems Preanalytic1979-01-10
ASSAY SYSTEM, FERRITIN I KIT (K781888)New England Nuclear1979-01-10
FERRITIN KIT (K781844)Ria Products, Inc.1979-01-10
RIA SYSTEM FOR HUMAN FE-RITIN (K781527)Calbiochem-Behring Corp.1978-10-03

Track JMG automatically

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