The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Hemolab Silimat Reagent.
| Device ID | K920001 |
| 510k Number | K920001 |
| Device Name: | HEMOLAB SILIMAT REAGENT |
| Classification | Osteotome, Manual |
| 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 | GFI |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-02 |
| Decision Date | 1992-09-25 |