FDA product code GPG: Antigen, Latex Agglutination, Trichinella Spiralis
GPG is the FDA product code for antigen, latex agglutination, trichinella spiralis. It is a Class I device, regulated under 21 CFR 866.3850 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GPG, from 2 different applicants. The average 510(k) review took 100 days (median 100).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Latex Agglutination, Trichinella Spiralis |
| Device class | Class I |
| Regulation | 21 CFR 866.3850 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GPG clearance
Top GPG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lmd Laboratories | 1 | 1991-03-21 |
| Utah Bioresearch, Inc. | 1 | 1988-07-01 |
Most recent GPG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904613 | Lmd Laboratories | TRICHINELLA SEROLOGY MICROTITER ELISA | 1991-03-21 | 161 |
| K882149 | Utah Bioresearch, Inc. | MINIFUGE, MODEL 70 | 1988-07-01 | 39 |
Recalls for GPG devices
openFDA lists no recalls for product code GPG.
Frequently asked questions
What is FDA product code GPG?
GPG is the FDA product code for antigen, latex agglutination, trichinella spiralis. It is a Class I device, regulated under 21 CFR 866.3850 and reviewed by the Microbiology panel.
What device class is GPG?
Class I, regulation 21 CFR 866.3850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GPG?
Across 2 cleared submissions the average was 100 days from receipt to decision (median 100).
Which companies have the most GPG clearances?
Lmd Laboratories (1); Utah Bioresearch, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GPG
- Run a recall and safety report across every GPG manufacturer
- Watch product code GPG 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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