K894845 is an FDA 510(k) clearance for the (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE. This device is classified as a Antisera, Latex Agglutination, Cryptococcus Neoformans (Class II - Special Controls, product code GMD).
Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 8, 1989, 28 days after receiving the submission on August 11, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K894845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1989 |
| Decision Date | September 08, 1989 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMD — Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3165 |