The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Slidex Rota-kit 2.
| Device ID | K895805 |
| 510k Number | K895805 |
| Device Name: | SLIDEX ROTA-KIT 2 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| 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 | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-28 |
| Decision Date | 1991-02-26 |