GMM — Antigens, Iha, Toxoplasma Gondii Class II
FDA product code GMM covers "Antigens, Iha, Toxoplasma Gondii", a Class II medical device regulated under 21 CFR 866.3780. Submissions are reviewed by the Microbiology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GMM
- Device Class
- Class II
- Regulation Number
- 866.3780
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K981263 | instrumentation laboratory | TOXOGEN | August 6, 1998 |
| K952818 | pyramid biological | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | November 20, 1995 |
| K851976 | si sero-immuno diagnostics | HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT | October 16, 1985 |
| K851977 | si sero-immuno diagnostics | HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT | October 16, 1985 |
| K830870 | parasitic disease consultants | POLYCHACO INDIRECT HEMAGGLUTINATION | August 12, 1983 |
| K802452 | syn-kit | TOXOTEST-MT EIKEN KIT | December 18, 1980 |
| K790460 | calbiochem-behring | TXOCELL-IHA REAGENT SYSTEM | May 25, 1979 |
| K771560 | burroughs wellcome | TOXHA TEST | September 15, 1977 |