The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vitek Gram Positive Identification Card (gpi).
| Device ID | K952095 |
| 510k Number | K952095 |
| Device Name: | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) |
| Classification | Gram Positive Identification Panel |
| 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 | LQL |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-04 |
| Decision Date | 1996-03-12 |
| Summary: | summary |