The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Ams Ana Card.
| Device ID | K843686 |
| 510k Number | K843686 |
| Device Name: | AMS ANA CARD |
| Classification | Kit, Anaerobic Identification |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Joan Metcalf |
| Correspondent | Joan Metcalf VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | JSP |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-18 |
| Decision Date | 1984-12-12 |