FDA Product Code JMG: Radioimmunoassay (two-site Solid Phase), Ferritin
Leading manufacturers include Beckman Coulter, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Diagnostic Products Corp..
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
Cleared
Mar 20, 2024
Access Ferritin
Beckman Coulter, Inc.
Immunology
90d
Cleared
Aug 19, 2005
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
Beckman Coulter, Inc.
Immunology
17d
Cleared
Jul 30, 1997
TINA-QUANT FERRITIN ASSAY
Boehringer Mannheim Corp.
Immunology
275d
Cleared
Jun 02, 1997
ELECSYS FERRITIN
Boehringer Mannheim Corp.
Immunology
14d
Cleared
Jan 13, 1993
IMMULITE FERRITIN
Diagnostic Products Corp.
Immunology
56d
Cleared
Jun 19, 1992
COBAS CORE FERRITIN EIA
Roche Diagnostic Systems, Inc.
Immunology
116d
Cleared
Aug 02, 1990
MILENIA (TM) FERRITIN
Diagnostic Products Corp.
Chemistry
31d
Cleared
Apr 21, 1988
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
Baxter Healthcare Corp
Immunology
36d
Cleared
Apr 03, 1981
QUANTIMUNE FERRITIN IRMA
Bio-Rad
Chemistry
11d
Cleared
Jan 11, 1980
TERRITIN RIA KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology
25d
Cleared
Jan 10, 1979
RIA KIT, FERRITIN SOLID PHASE
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
50d
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.