The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Crypto-lex System.
| Device ID | K930418 |
| 510k Number | K930418 |
| Device Name: | CRYPTO-LEX SYSTEM |
| Classification | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Applicant | TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 Raleigh, NC 27613 |
| Contact | Bruce A Clinton |
| Correspondent | Bruce A Clinton TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 Raleigh, NC 27613 |
| Product Code | GMD |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1994-02-17 |