The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Lyme-check(tm) Test Kit.
| Device ID | K896378 |
| 510k Number | K896378 |
| Device Name: | LYME-CHECK(TM) TEST KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge, NY 11788 |
| Contact | Imre Pinter |
| Correspondent | Imre Pinter DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge, NY 11788 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1991-11-05 |