FDA product code GMM: Antigens, Iha, Toxoplasma Gondii
GMM is the FDA product code for antigens, iha, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under GMM, from 7 different applicants. The average 510(k) review took 116 days (median 134).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Iha, Toxoplasma Gondii |
| Device class | Class II |
| Regulation | 21 CFR 866.3780 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GMM clearance
Top GMM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Si Sero-Immuno Diagnostics, Inc. | 2 | 1985-10-16 |
| Instrumentation Laboratory CO | 1 | 1998-08-06 |
| Pyramid Biological Corp. | 1 | 1995-11-20 |
| Parasitic Disease Consultants | 1 | 1983-08-12 |
| Syn-Kit, Inc. | 1 | 1980-12-18 |
2 more applicants have GMM clearances. See the full list in Caduvo.
Most recent GMM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981263 | Instrumentation Laboratory CO | TOXOGEN | 1998-08-06 | 121 |
| K952818 | Pyramid Biological Corp. | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | 1995-11-20 | 153 |
| K851977 | Si Sero-Immuno Diagnostics, Inc. | HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT | 1985-10-16 | 162 |
| K851976 | Si Sero-Immuno Diagnostics, Inc. | HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT | 1985-10-16 | 162 |
| K830870 | Parasitic Disease Consultants | POLYCHACO INDIRECT HEMAGGLUTINATION | 1983-08-12 | 147 |
Recalls for GMM devices
openFDA lists no recalls for product code GMM.
Frequently asked questions
What is FDA product code GMM?
GMM is the FDA product code for antigens, iha, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel.
What device class is GMM?
Class II, regulation 21 CFR 866.3780. Typical premarket route: 510(k).
How long does a 510(k) take for product code GMM?
Across 8 cleared submissions the average was 116 days from receipt to decision (median 134).
Which companies have the most GMM clearances?
Si Sero-Immuno Diagnostics, Inc. (2); Instrumentation Laboratory CO (1); Pyramid Biological Corp. (1); Parasitic Disease Consultants (1); Syn-Kit, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMM
- Run a recall and safety report across every GMM manufacturer
- Watch product code GMM 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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