The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Lyme Stat M Test Kit.
| Device ID | K904652 |
| 510k Number | K904652 |
| Device Name: | LYME STAT M TEST KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Leif E Olsen |
| Correspondent | Leif E Olsen 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 | 1990-10-15 |
| Decision Date | 1991-10-21 |