The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fiax Test Kit For Lyme Disease Antibodies.
Device ID | K872247 |
510k Number | K872247 |
Device Name: | FIAX TEST KIT FOR LYME DISEASE ANTIBODIES |
Classification | Reagent, Borrelia Serological Reagent |
Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Contact | Louise M Harris |
Correspondent | Louise M Harris 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 | 1987-06-11 |
Decision Date | 1987-10-15 |