K812188 is an FDA 510(k) clearance for the CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI. This device is classified as a Antisera, Latex Agglutination, Cryptococcus Neoformans (Class II - Special Controls, product code GMD).
Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981, 28 days after receiving the submission on August 3, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K812188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1981 |
| Decision Date | August 31, 1981 |
| 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 |