JMG · Class II · 21 CFR 866.5340

FDA Product Code JMG: Radioimmunoassay (two-site Solid Phase), Ferritin

Leading manufacturers include Diagnostic Products Corp., Boehringer Mannheim Corp. and Beckman Coulter, Inc..

24
Total
24
Cleared
64d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Radioimmunoassay (two-site Solid Phase), Ferritin Devices (Product Code JMG)

24 devices
1–24 of 24
Cleared Mar 20, 2024
Access Ferritin
K234052
Beckman Coulter, Inc.
Immunology · 90d
Cleared Aug 19, 2005
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
K052082
Beckman Coulter, Inc.
Immunology · 17d
Cleared Jul 30, 1997
TINA-QUANT FERRITIN ASSAY
K964282
Boehringer Mannheim Corp.
Immunology · 275d
Cleared Jun 02, 1997
ELECSYS FERRITIN
K971833
Boehringer Mannheim Corp.
Immunology · 14d
Cleared Jan 13, 1993
IMMULITE FERRITIN
K925848
Diagnostic Products Corp.
Immunology · 56d
Cleared Jan 13, 1993
ACCESS FERRITIN ASSAY
K926221
Bio-Rad Laboratories, Inc.
Immunology · 34d
Cleared Jun 19, 1992
COBAS CORE FERRITIN EIA
K920829
Roche Diagnostic Systems, Inc.
Immunology · 116d
Cleared Jun 04, 1992
CEDIA FERRITIN ASSAY
K920318
Microgenics Corp.
Chemistry · 132d
Cleared Aug 02, 1990
MILENIA (TM) FERRITIN
K902997
Diagnostic Products Corp.
Chemistry · 31d
Cleared Apr 21, 1988
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
K881138
Baxter Healthcare Corp
Immunology · 36d
Cleared Nov 04, 1987
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT
K873730
Medix Biotech, Inc.
Hematology · 50d
Cleared Aug 21, 1987
DELFIA(TM) FERRITIN KIT
K872955
Lkb Instruments, Inc.
Microbiology · 23d
Cleared Mar 30, 1984
CORNINGS MAGIC FERRITIN RADIOIMMUNO-
K840460
Corning Medical & Scientific
Chemistry · 57d
Cleared Apr 03, 1981
QUANTIMUNE FERRITIN IRMA
K810799
Bio-Rad
Chemistry · 11d
Cleared Jan 11, 1980
TERRITIN RIA KIT
K792588
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 25d
Cleared Aug 03, 1979
RADIOIMMUNOASSAY TEST SYSTEM
K791096
Corning Medical & Scientific
Immunology · 52d
Cleared Jan 10, 1979
RIA KIT, FERRITIN SOLID PHASE
K781946
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 50d
Cleared Oct 03, 1978
RIA SYSTEM FOR HUMAN FE-RITIN
K781527
Calbiochem-Behring Corp.
Immunology · 28d

About Product Code JMG - Regulatory Context

510(k) Submission Activity

24 total 510(k) submissions under product code JMG since 1978, with 24 receiving FDA clearance (average review time: 64 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.