FDA product code GRM: Antisera, All Groups, Salmonella Spp.
GRM is the FDA product code for antisera, all groups, salmonella spp.. It is a Class II device, regulated under 21 CFR 866.3550 and reviewed by the Microbiology panel. FDA has cleared 69 510(k) submissions under GRM, from 6 different applicants. The average 510(k) review took 54 days (median 48). FDA has posted 1 recall for GRM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All Groups, Salmonella Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3550 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GRM clearance
Top GRM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sa Scientific, Inc. | 64 | 1996-06-18 |
| S.M.I. Medical, Inc. | 1 | 1992-10-05 |
| Ampcor, Inc. | 1 | 1991-09-13 |
| Wellcome Diagnostics | 1 | 1989-02-16 |
| Armkel, LLC | 1 | 1987-04-22 |
1 more applicants have GRM clearances. See the full list in Caduvo.
Most recent GRM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961961 | Sa Scientific, Inc. | SAS SALMONELLA H F,G,T ANTISERUM | 1996-06-18 | 29 |
| K961948 | Sa Scientific, Inc. | SAS SALMONELLA O FACTOR 20 ANTISERUM | 1996-06-18 | 29 |
| K961957 | Sa Scientific, Inc. | SAS SALMONELLA H Z4, Z32 ANTISERUM | 1996-06-18 | 29 |
| K961964 | Sa Scientific, Inc. | SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM | 1996-06-18 | 29 |
| K961954 | Sa Scientific, Inc. | SAS SALMONELLA H Z35 ANTISERUM | 1996-06-18 | 29 |
Recalls for GRM devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-03-25.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code GRM?
GRM is the FDA product code for antisera, all groups, salmonella spp.. It is a Class II device, regulated under 21 CFR 866.3550 and reviewed by the Microbiology panel.
What device class is GRM?
Class II, regulation 21 CFR 866.3550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRM?
Across 69 cleared submissions the average was 54 days from receipt to decision (median 48).
Which companies have the most GRM clearances?
Sa Scientific, Inc. (64); S.M.I. Medical, Inc. (1); Ampcor, Inc. (1); Wellcome Diagnostics (1); Armkel, LLC (1).
Have GRM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code GRM
- Run a recall and safety report across every GRM manufacturer
- Watch product code GRM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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