The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Lyme-spot If Kit.
| Device ID | K910230 |
| 510k Number | K910230 |
| Device Name: | LYME-SPOT IF KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Cheryl Winters-head |
| Correspondent | Cheryl Winters-head VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-18 |
| Decision Date | 1991-08-30 |