K120946 is an FDA 510(k) clearance for the ALPHA CRYPTOCOCCAL ANTIGEN EIA. This device is classified as a Antigen, Elisa, Cryptococcus (Class II - Special Controls, product code MDU).
Submitted by Immuno-Mycologics, Inc. (Norman, US). The FDA issued a Cleared decision on December 17, 2012, 263 days after receiving the submission on March 29, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K120946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2012 |
| Decision Date | December 17, 2012 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MDU — Antigen, Elisa, Cryptococcus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3165 |