The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vitek Gram-negative Identification Card.
| Device ID | K883558 |
| 510k Number | K883558 |
| Device Name: | VITEK GRAM-NEGATIVE IDENTIFICATION CARD |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | L Metcalf |
| Correspondent | L Metcalf VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-19 |
| Decision Date | 1988-09-16 |