The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Fdp - Slidex Direct.
| Device ID | K921989 |
| 510k Number | K921989 |
| Device Name: | FDP - SLIDEX DIRECT |
| Classification | Fibrin Split Products |
| 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 | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1993-11-03 |