Panels › Microbiology › Product code MDU · Class 2
Antigen, Elisa, Cryptococcus
Regulation 866.3165
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MDU
| Company | 510(k)s | Recalls |
|---|---|---|
| Immuno-Mycologics, Inc. | 1 | 0 |
| Meridian Bioscience Inc | 0 | 1 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2012 | K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA Immuno-Mycologics, Inc. | MDU |
| Jan 25, 1991 | K904393 | PREMIER-CRYPTOCOCCAL ANTIGEN Meridian Diagnostics, Inc. | MDU |
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