The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Ams Gram-positive Ident. Card.
| Device ID | K834389 |
| 510k Number | K834389 |
| Device Name: | AMS GRAM-POSITIVE IDENT. CARD |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | VITEK SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-14 |
| Decision Date | 1984-03-09 |