The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Biomerieux Uniplasmatrol Normal & Abnormal.
| Device ID | K930267 |
| 510k Number | K930267 |
| Device Name: | BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL |
| Classification | Control, Plasma, Abnormal |
| 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 | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-19 |
| Decision Date | 1994-03-22 |