K810510 is an FDA 510(k) clearance for the YA-CRYPTO ANTIBODY TUBE AGGLUTINATION. This device is classified as a Antisera, Latex Agglutination, Cryptococcus Neoformans (Class II - Special Controls, product code GMD).
Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 20, 1981, 24 days after receiving the submission on February 24, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K810510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1981 |
| Decision Date | March 20, 1981 |
| Days to Decision | 24 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 |