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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2019 | Immuno-Mycologics, Inc Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Te Terminated |
GMJ | K830837 |
| Jun 20, 2016 | Immuno-Mycologics, Inc Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150
The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to a Terminated |
GMJ | K791393 |
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