FDA product code GMJ: Antigens, Histoplasma Capsulatum, All
GMJ is the FDA product code for antigens, histoplasma capsulatum, all. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel. FDA has cleared 12 510(k) submissions under GMJ, from 5 different applicants. The average 510(k) review took 31 days (median 29). FDA has posted 2 recalls for GMJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Histoplasma Capsulatum, All |
| 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 GMJ clearance
Top GMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno-Mycologics, Inc. | 4 | 1983-05-05 |
| Meridian Diagnostics, Inc. | 4 | 1980-01-23 |
| I M, Inc. | 2 | 1976-11-01 |
| American Scientific Products | 1 | 1981-12-31 |
| Nolan Biological Laboratories, Inc. | 1 | 1980-09-26 |
Most recent GMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830837 | Immuno-Mycologics, Inc. | LA-HISTO ANTIBODY SYSTEM #HL 1001 | 1983-05-05 | 50 |
| K813359 | American Scientific Products | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | 1981-12-31 | 31 |
| K802130 | Nolan Biological Laboratories, Inc. | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | 1980-09-26 | 53 |
| K792701 | Meridian Diagnostics, Inc. | HISTOPLASMA CAPSULATUM, ANTIGEN | 1980-01-23 | 27 |
| K792711 | Meridian Diagnostics, Inc. | HISTOPLASMA CAPSULATUM, ANTISERUM | 1980-01-17 | 21 |
Recalls for GMJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-04.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code GMJ?
GMJ is the FDA product code for antigens, histoplasma capsulatum, all. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel.
What device class is GMJ?
Class II, regulation 21 CFR 866.3320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GMJ?
Across 12 cleared submissions the average was 31 days from receipt to decision (median 29).
Which companies have the most GMJ clearances?
Immuno-Mycologics, Inc. (4); Meridian Diagnostics, Inc. (4); I M, Inc. (2); American Scientific Products (1); Nolan Biological Laboratories, Inc. (1).
Have GMJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-11-04.
Next steps
- Run an FDA pathway report with predicate devices for product code GMJ
- Run a recall and safety report across every GMJ manufacturer
- Watch product code GMJ 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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