The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Slidex Staph-kit.
| Device ID | K923212 |
| 510k Number | K923212 |
| Device Name: | SLIDEX STAPH-KIT |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Contact | David K Broadway |
| Correspondent | David K Broadway BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1992-09-28 |