FDA product code GMK: Antiserum, Positive Control, Histoplasma Capsulatum
GMK is the FDA product code for antiserum, positive control, histoplasma capsulatum. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under GMK, from 3 different applicants. The average 510(k) review took 27 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Positive Control, Histoplasma Capsulatum |
| Device class | Class II |
| Regulation | 21 CFR 866.3320 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GMK clearance
Top GMK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 4 | 1980-01-24 |
| Immuno-Mycologics, Inc. | 3 | 1979-08-16 |
| I M, Inc. | 2 | 1976-11-01 |
Most recent GMK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792694 | Meridian Diagnostics, Inc. | NEGATIVE CONTROL SERUM | 1980-01-24 | 28 |
| K792692 | Meridian Diagnostics, Inc. | IMMUNODIFFUSION BAND INTENSIFYING FLUID | 1980-01-24 | 28 |
| K792718 | Meridian Diagnostics, Inc. | HISTOPLASMA CAPSULATUM, ANTISERUM | 1980-01-17 | 21 |
| K792679 | Meridian Diagnostics, Inc. | HISTOPLASMA CAPSULATUM, ANTISERUM | 1980-01-17 | 21 |
| K791395 | Immuno-Mycologics, Inc. | ANTI-HISTOPLASMA SERUM #CF10025X | 1979-08-16 | 36 |
Recalls for GMK devices
openFDA lists no recalls for product code GMK.
Frequently asked questions
What is FDA product code GMK?
GMK is the FDA product code for antiserum, positive control, histoplasma capsulatum. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel.
What device class is GMK?
Class II, regulation 21 CFR 866.3320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GMK?
Across 9 cleared submissions the average was 27 days from receipt to decision (median 28).
Which companies have the most GMK clearances?
Meridian Diagnostics, Inc. (4); Immuno-Mycologics, Inc. (3); I M, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GMK
- Run a recall and safety report across every GMK manufacturer
- Watch product code GMK 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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