FDA product code GRL: Antigens, All Groups, Salmonella Spp.
GRL is the FDA product code for antigens, 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 2 510(k) submissions under GRL, from 2 different applicants. The average 510(k) review took 60 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, 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 GRL clearance
Top GRL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sa Scientific, Inc. | 1 | 1995-03-07 |
| Fisher Scientific Co., LLC | 1 | 1982-05-03 |
Most recent GRL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945839 | Sa Scientific, Inc. | SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA | 1995-03-07 | 97 |
| K820996 | Fisher Scientific Co., LLC | SALMONELLA & SHIGELLA GROUPING SERA | 1982-05-03 | 24 |
Recalls for GRL devices
openFDA lists no recalls for product code GRL.
Frequently asked questions
What is FDA product code GRL?
GRL is the FDA product code for antigens, 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 GRL?
Class II, regulation 21 CFR 866.3550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRL?
Across 2 cleared submissions the average was 60 days from receipt to decision (median 60).
Which companies have the most GRL clearances?
Sa Scientific, Inc. (1); Fisher Scientific Co., LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRL
- Run a recall and safety report across every GRL manufacturer
- Watch product code GRL 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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