Panels › Microbiology › Product code GMM · Class 2
Antigens, Iha, Toxoplasma Gondii
Regulation 866.3780
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GMM
| Company | 510(k)s | Recalls |
|---|---|---|
| Si Sero-Immuno Diagnostics, Inc. | 2 | 0 |
| Burroughs Wellcome Co. | 1 | 0 |
| Calbiochem-Behring Corp. | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Parasitic Disease Consultants | 1 | 0 |
| Pyramid Biological Corp. | 1 | 0 |
| Syn-Kit, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 1998 | K981263 | TOXOGEN Instrumentation Laboratory CO | GMM |
| Nov 20, 1995 | K952818 | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII Pyramid Biological Corp. | GMM |
| Oct 16, 1985 | K851977 | HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT Si Sero-Immuno Diagnostics, Inc. | GMM |
| Oct 16, 1985 | K851976 | HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT Si Sero-Immuno Diagnostics, Inc. | GMM |
| Aug 12, 1983 | K830870 | POLYCHACO INDIRECT HEMAGGLUTINATION Parasitic Disease Consultants | GMM |
| Dec 18, 1980 | K802452 | TOXOTEST-MT EIKEN KIT Syn-Kit, Inc. | GMM |
| May 25, 1979 | K790460 | TXOCELL-IHA REAGENT SYSTEM Calbiochem-Behring Corp. | GMM |
| Sep 15, 1977 | K771560 | TOXHA TEST Burroughs Wellcome Co. | GMM |
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