K904393 is an FDA 510(k) clearance for the PREMIER-CRYPTOCOCCAL ANTIGEN. This device is classified as a Antigen, Elisa, Cryptococcus (Class II - Special Controls, product code MDU).
Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 25, 1991, 122 days after receiving the submission on September 25, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K904393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1990 |
| Decision Date | January 25, 1991 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | MDU — Antigen, Elisa, Cryptococcus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3165 |