LYME STAT TEST KIT

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 Lyme Stat Test Kit.

Pre-market Notification Details

Device IDK875286
510k NumberK875286
Device Name:LYME STAT TEST KIT
ClassificationReagent, Borrelia Serological Reagent
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
ContactMarie P Reeves
CorrespondentMarie P Reeves
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 Received1987-12-29
Decision Date1988-03-30

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