Panels › Microbiology › Product code GMH · Class 2
Antiserum, Positive Control, 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 GMH
| Company | 510(k)s | Recalls |
|---|---|---|
| Meridian Diagnostics, Inc. | 3 | 0 |
| I M, Inc. | 1 | 0 |
| Immuno-Mycologics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 1980 | K792717 | COCCIDIOIDES IMMITIS, ANTISERUM POS. Meridian Diagnostics, Inc. | GMH |
| Jan 17, 1980 | K792688 | COCCIDIOIDES IMMITIS, ANTISERUM Meridian Diagnostics, Inc. | GMH |
| Jan 17, 1980 | K792684 | COCCIDIOIDES IMMITIS, ANTISERUM, Meridian Diagnostics, Inc. | GMH |
| Aug 16, 1979 | K791388 | ANTI-COCCIDIOIDES SERUM #CF10028X Immuno-Mycologics, Inc. | GMH |
| Nov 1, 1976 | K760834 | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) I M, Inc. | GMH |
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