The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Staph-a-lex(tm) System.
| Device ID | K926173 |
| 510k Number | K926173 |
| Device Name: | STAPH-A-LEX(TM) SYSTEM |
| Classification | Kit, Screening, Staphylococcus Aureus |
| 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 | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-08 |
| Decision Date | 1993-08-10 |