The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Gram Negative Identification Plus Card.
| Device ID | K962609 |
| 510k Number | K962609 |
| Device Name: | GRAM NEGATIVE IDENTIFICATION PLUS CARD |
| Classification | Instrument For Auto Reader Of Overnight Microorganism Identification System |
| 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 | LRH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-03 |
| Decision Date | 1996-08-30 |
| Summary: | summary |