The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Slidex Meningite-kit 5.
| Device ID | K910210 |
| 510k Number | K910210 |
| Device Name: | SLIDEX MENINGITE-KIT 5 |
| Classification | Antisera, All Groups, N. Meningitidis |
| 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 | GTJ |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-08-12 |