The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Lyme Stat Test Kit.
| Device ID | K875286 |
| 510k Number | K875286 |
| Device Name: | LYME STAT TEST KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Marie P Reeves |
| Correspondent | Marie P Reeves WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-03-30 |