K102286 is an FDA 510(k) clearance for the CRAG LATERAL FLOW ASSAY (CRAG LFA). This device is classified as a Antisera, Latex Agglutination, Cryptococcus Neoformans (Class II - Special Controls, product code GMD).
Submitted by Immuno-Mycologics, Inc. (Norman, US). The FDA issued a Cleared decision on July 20, 2011, 342 days after receiving the submission on August 12, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K102286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2010 |
| Decision Date | July 20, 2011 |
| Days to Decision | 342 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GMD — Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3165 |