The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Slidex Strepto-kit.
| Device ID | K905020 |
| 510k Number | K905020 |
| Device Name: | SLIDEX STREPTO-KIT |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| 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 | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-01-28 |