FIAX TEST KIT FOR LYME DISEASE ANTIBODIES

Reagent, Borrelia Serological Reagent

WHITTAKER BIOPRODUCTS, INC.

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.

Pre-market Notification Details

Device IDK872247
510k NumberK872247
Device Name:FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
ClassificationReagent, Borrelia Serological Reagent
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
ContactLouise M Harris
CorrespondentLouise M Harris
WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-11
Decision Date1987-10-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.