The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Hemolab Protein C Chromogenic Assay.
| Device ID | K934210 |
| 510k Number | K934210 |
| Device Name: | HEMOLAB PROTEIN C CHROMOGENIC ASSAY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Contact | Cheryl Winters-heard |
| Correspondent | Cheryl Winters-heard BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-30 |
| Decision Date | 1994-12-22 |