Panels › Microbiology › Product code GMG · Class 2
Antigen, Latex Agglutination, Coccidioides Immitis
Regulation 866.3135
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GMG
| Company | 510(k)s | Recalls |
|---|---|---|
| I M, Inc. | 2 | 0 |
| American Scientific Products | 1 | 0 |
| Immuno-Mycologics, Inc. | 1 | 0 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 1981 | K812189 | COCCIDIOIDES LATEX AGGLUTINATION American Scientific Products | GMG |
| Jan 17, 1980 | K792690 | COCCIDIOIDES IMMITIS, LATEX AGGLUTI Meridian Diagnostics, Inc. | GMG |
| Aug 16, 1979 | K791381 | COCCIDIODES (COCCI) Immuno-Mycologics, Inc. | GMG |
| Feb 1, 1979 | K782070 | REAGENT, COCCI LATEX I M, Inc. | GMG |
| Nov 1, 1976 | K760829 | COCCIDIOIDES MYCELIAL ANTIGEN I M, Inc. | GMG |
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