K933997 is an FDA 510(k) clearance for the PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY. This device is classified as a Antisera, Latex Agglutination, Cryptococcus Neoformans (Class II - Special Controls, product code GMD).
Submitted by Alexon Biomedical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 22, 1993, 97 days after receiving the submission on August 17, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K933997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1993 |
| Decision Date | November 22, 1993 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GMD — Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3165 |