Panels › Microbiology › Product code GMJ · Class 2
Antigens, Histoplasma Capsulatum, All
Regulation 866.3320
0510(k)s in 12 months (12 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GMJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Immuno-Mycologics, Inc. | 4 | 2 |
| Meridian Diagnostics, Inc. | 4 | 0 |
| I M, Inc. | 2 | 0 |
| American Scientific Products | 1 | 0 |
| Nolan Biological Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 1983 | K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 Immuno-Mycologics, Inc. | GMJ |
| Dec 31, 1981 | K813359 | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL American Scientific Products | GMJ |
| Sep 26, 1980 | K802130 | IMMUNO. IDENTIFICATION OF H. CAPSULATUM Nolan Biological Laboratories, Inc. | GMJ |
| Jan 23, 1980 | K792701 | HISTOPLASMA CAPSULATUM, ANTIGEN Meridian Diagnostics, Inc. | GMJ |
| Jan 17, 1980 | K792711 | HISTOPLASMA CAPSULATUM, ANTISERUM Meridian Diagnostics, Inc. | GMJ |
| Jan 17, 1980 | K792708 | HISTOPLASMA CAPSULATUM, MYCELIAL PHASE Meridian Diagnostics, Inc. | GMJ |
| Jan 17, 1980 | K792704 | HISTOPLASMA CAPSULATUM, ANTIGEN YEAST Meridian Diagnostics, Inc. | GMJ |
| Aug 16, 1979 | K791394 | HISTOPLASMA MYCELIAL #CF10020X Immuno-Mycologics, Inc. | GMJ |
| Aug 16, 1979 | K791393 | HISTOPLASMA YEAST ANTI #CF10021X Immuno-Mycologics, Inc. | GMJ |
| Aug 16, 1979 | K791384 | FUNGAL IMMUNODIFFUSION KIT #ID1001 Immuno-Mycologics, Inc. | GMJ |
| Nov 1, 1976 | K760827 | HISTOPLASMA YEAST ANTIGEN I M, Inc. | GMJ |
| Nov 1, 1976 | K760826 | HISTOPLASMA MYCELIAL ANTIGEN I M, Inc. | GMJ |
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