The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fiax Lyme M Test Kit.
| Device ID | K904893 |
| 510k Number | K904893 |
| Device Name: | FIAX LYME M TEST KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Wilma Galliker |
| Correspondent | Wilma Galliker 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 | 1990-10-30 |
| Decision Date | 1991-10-16 |