FDA product code GOM: Antisera, Cf, Rubella
GOM is the FDA product code for antisera, cf, rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GOM. The average 510(k) review took 102 days (median 102).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Cf, Rubella |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GOM clearance
Top GOM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pyramid Biological Corp. | 2 | 1995-12-20 |
Most recent GOM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954515 | Pyramid Biological Corp. | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA | 1995-12-20 | 83 |
| K953826 | Pyramid Biological Corp. | ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA | 1995-12-14 | 121 |
Recalls for GOM devices
openFDA lists no recalls for product code GOM.
Frequently asked questions
What is FDA product code GOM?
GOM is the FDA product code for antisera, cf, rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is GOM?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code GOM?
Across 2 cleared submissions the average was 102 days from receipt to decision (median 102).
Which companies have the most GOM clearances?
Pyramid Biological Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GOM
- Run a recall and safety report across every GOM manufacturer
- Watch product code GOM 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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