FDA product code GPO: Antigen, Cf, Typhus Fever Group
GPO is the FDA product code for antigen, cf, typhus fever group. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GPO. The average 510(k) review took 92 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, Typhus Fever Group |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GPO clearance
Top GPO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Behring Diagnostics, Inc. | 1 | 1992-12-01 |
Most recent GPO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924395 | Behring Diagnostics, Inc. | NEOTHROMITIN(R) | 1992-12-01 | 92 |
Recalls for GPO devices
openFDA lists no recalls for product code GPO.
Frequently asked questions
What is FDA product code GPO?
GPO is the FDA product code for antigen, cf, typhus fever group. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPO?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GPO?
Across 1 cleared submissions the average was 92 days from receipt to decision (median 92).
Which companies have the most GPO clearances?
Behring Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GPO
- Run a recall and safety report across every GPO manufacturer
- Watch product code GPO 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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