FDA product code GMH: Antiserum, Positive Control, Coccidioides Immitis
GMH is the FDA product code for antiserum, positive control, 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 GMH, from 3 different applicants. The average 510(k) review took 24 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Positive Control, 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 GMH clearance
Top GMH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 3 | 1980-01-17 |
| Immuno-Mycologics, Inc. | 1 | 1979-08-16 |
| I M, Inc. | 1 | 1976-11-01 |
Most recent GMH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792717 | Meridian Diagnostics, Inc. | COCCIDIOIDES IMMITIS, ANTISERUM POS. | 1980-01-17 | 21 |
| K792688 | Meridian Diagnostics, Inc. | COCCIDIOIDES IMMITIS, ANTISERUM | 1980-01-17 | 21 |
| K792684 | Meridian Diagnostics, Inc. | COCCIDIOIDES IMMITIS, ANTISERUM, | 1980-01-17 | 21 |
| K791388 | Immuno-Mycologics, Inc. | ANTI-COCCIDIOIDES SERUM #CF10028X | 1979-08-16 | 36 |
| K760834 | I M, Inc. | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) | 1976-11-01 | 19 |
Recalls for GMH devices
openFDA lists no recalls for product code GMH.
Frequently asked questions
What is FDA product code GMH?
GMH is the FDA product code for antiserum, positive control, coccidioides immitis. It is a Class II device, regulated under 21 CFR 866.3135 and reviewed by the Microbiology panel.
What device class is GMH?
Class II, regulation 21 CFR 866.3135. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GMH?
Across 5 cleared submissions the average was 24 days from receipt to decision (median 21).
Which companies have the most GMH clearances?
Meridian Diagnostics, Inc. (3); Immuno-Mycologics, Inc. (1); I M, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMH
- Run a recall and safety report across every GMH manufacturer
- Watch product code GMH 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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