FDA product code GMG: Antigen, Latex Agglutination, Coccidioides Immitis
GMG is the FDA product code for antigen, latex agglutination, coccidioides immitis. It is a Class II device, regulated under 21 CFR 866.3135 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under GMG, from 4 different applicants. The average 510(k) review took 30 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Latex Agglutination, Coccidioides Immitis |
| Device class | Class II |
| Regulation | 21 CFR 866.3135 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GMG clearance
Top GMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| I M, Inc. | 2 | 1979-02-01 |
| American Scientific Products | 1 | 1981-08-25 |
| Meridian Diagnostics, Inc. | 1 | 1980-01-17 |
| Immuno-Mycologics, Inc. | 1 | 1979-08-16 |
Most recent GMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812189 | American Scientific Products | COCCIDIOIDES LATEX AGGLUTINATION | 1981-08-25 | 22 |
| K792690 | Meridian Diagnostics, Inc. | COCCIDIOIDES IMMITIS, LATEX AGGLUTI | 1980-01-17 | 21 |
| K791381 | Immuno-Mycologics, Inc. | COCCIDIODES (COCCI) | 1979-08-16 | 36 |
| K782070 | I M, Inc. | REAGENT, COCCI LATEX | 1979-02-01 | 51 |
| K760829 | I M, Inc. | COCCIDIOIDES MYCELIAL ANTIGEN | 1976-11-01 | 19 |
Recalls for GMG devices
openFDA lists no recalls for product code GMG.
Frequently asked questions
What is FDA product code GMG?
GMG is the FDA product code for antigen, latex agglutination, coccidioides immitis. It is a Class II device, regulated under 21 CFR 866.3135 and reviewed by the Microbiology panel.
What device class is GMG?
Class II, regulation 21 CFR 866.3135. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GMG?
Across 5 cleared submissions the average was 30 days from receipt to decision (median 22).
Which companies have the most GMG clearances?
I M, Inc. (2); American Scientific Products (1); Meridian Diagnostics, Inc. (1); Immuno-Mycologics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMG
- Run a recall and safety report across every GMG manufacturer
- Watch product code GMG 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times