K930418 is an FDA 510(k) clearance for the CRYPTO-LEX SYSTEM. This device is classified as a Antisera, Latex Agglutination, Cryptococcus Neoformans (Class II - Special Controls, product code GMD).
Submitted by Trinity Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on February 17, 1994, 387 days after receiving the submission on January 26, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.
| 510(k) Number | K930418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1993 |
| Decision Date | February 17, 1994 |
| Days to Decision | 387 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 |