The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Rapid Coryne Syst/identif Of Coryneform Bacteria.
| Device ID | K910304 |
| 510k Number | K910304 |
| Device Name: | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA |
| Classification | Gram Positive Identification Panel |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | David K Broadway |
| Correspondent | David K Broadway VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 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 | 1991-01-24 |
| Decision Date | 1991-07-26 |