GRMClass II

Antisera, All Groups, Salmonella Spp.

21 CFR 866.3550 / Microbiology

GRM is the FDA product code for Antisera, All Groups, Salmonella Spp., a class II device type, regulated under 21 CFR 866.3550. As of 2026-09-10, FDA records hold 69 510(k) clearances under this code, the most recent dated 1996-06-18, and one recall.

Classification record

Product code: GRM
Device name: Antisera, All Groups, Salmonella Spp.
Regulation: 21 CFR 866.3550
Device class: Class II
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 69
Ingested recalls: 1

Clearances, product code GRM

By decision year

69 clearances under product code GRM with a decision year between 1982 and 1996, 1996 the highest year at 59.

Show the numbers

510(k) clearances under FDA product code GRM by decision year
Year	Clearances
1982	1
1987	1
1989	1
1991	1
1992	1
1994	1
1995	4
1996	59

Applicants with the most clearances

Product code GRM

Applicants holding the most 510(k) clearances under product code GRM
Applicant	Clearances
SA Scientific, Ltd	64
Ampcor, Inc.	1
Analytical Products, Inc.	1
Armkel, LLC	1
S.M.I. Medical, Inc.	1
Wellcome Diagnostics	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order