Panels › Microbiology › Product code GMK · Class 2
Antiserum, Positive Control, Histoplasma Capsulatum
Regulation 866.3320
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GMK
| Company | 510(k)s | Recalls |
|---|---|---|
| Meridian Diagnostics, Inc. | 4 | 0 |
| Immuno-Mycologics, Inc. | 3 | 0 |
| I M, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 1980 | K792694 | NEGATIVE CONTROL SERUM Meridian Diagnostics, Inc. | GMK |
| Jan 24, 1980 | K792692 | IMMUNODIFFUSION BAND INTENSIFYING FLUID Meridian Diagnostics, Inc. | GMK |
| Jan 17, 1980 | K792718 | HISTOPLASMA CAPSULATUM, ANTISERUM Meridian Diagnostics, Inc. | GMK |
| Jan 17, 1980 | K792679 | HISTOPLASMA CAPSULATUM, ANTISERUM Meridian Diagnostics, Inc. | GMK |
| Aug 16, 1979 | K791395 | ANTI-HISTOPLASMA SERUM #CF10025X Immuno-Mycologics, Inc. | GMK |
| Aug 16, 1979 | K791392 | ANTI-HISTOPLASMA SERUM #CF10026X Immuno-Mycologics, Inc. | GMK |
| Aug 16, 1979 | K791390 | ANTI-BLASTOMYCES SERUM #CF10027X Immuno-Mycologics, Inc. | GMK |
| Nov 1, 1976 | K760832 | ANTI-HISTOPLASMA CONTROL SERUM (YEAST) I M, Inc. | GMK |
| Nov 1, 1976 | K760831 | ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) I M, Inc. | GMK |
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