HEMOLAB
Instrument, Coagulation, Automated
BIOMERIEUX VITEK, INC.
The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Hemolab.
Pre-market Notification Details
| Device ID | K931992 |
| 510k Number | K931992 |
| Device Name: | HEMOLAB |
| Classification | Instrument, Coagulation, Automated |
| 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 | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-23 |
| Decision Date | 1994-12-22 |
Trademark Results [HEMOLAB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOLAB 74225969 not registered Dead/Abandoned |
BIO MERIEUX 1991-11-27 |
 HEMOLAB 72372521 0968101 Dead/Cancelled |
PARTICLE DATA, INC. 1970-10-05 |
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