JMGClass II

Radioimmunoassay (Two-Site Solid Phase), Ferritin

21 CFR 866.5340 / Immunology

JMG is the FDA product code for Radioimmunoassay (Two-Site Solid Phase), Ferritin, a class II device type, regulated under 21 CFR 866.5340. As of 2026-09-10, FDA records hold 24 510(k) clearances under this code, the most recent dated 2024-03-20, and 5 recalls.

Classification record

Product code: JMG
Device name: Radioimmunoassay (Two-Site Solid Phase), Ferritin
Regulation: 21 CFR 866.5340
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 24
Ingested recalls: 5

Clearances, product code JMG

By decision year

24 clearances under product code JMG with a decision year between 1978 and 2024, 1979 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code JMG by decision year
Year	Clearances
1978	1
1979	5
1980	1
1981	1
1984	1
1987	2
1988	1
1989	1
1990	1
1992	2
1993	2
1995	1
1997	3
2005	1
2024	1

Applicants with the most clearances

Product code JMG

Applicants holding the most 510(k) clearances under product code JMG
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	4
BD Becton Dickinson Vacutainer Systems Preanalytic	2
Boehringer Mannheim Corp.	2
Corning Medical & Scientific	2
Baxter Healthcare Corporation	1
Bio-Rad	1
Bio-Rad Laboratories Inc.	1
Calbiochem-Behring Corp.	1
Cambridge Medical Technology	1
Dade Chemistry Systems, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order