BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM

Reagent, Borrelia Serological Reagent

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Borrelia Burgdorferi Igg Western Blot Test System.

Pre-market Notification Details

Device IDK991180
510k NumberK991180
Device Name:BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
ClassificationReagent, Borrelia Serological Reagent
Applicant ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
ContactMark J Kopnitsky
CorrespondentMark J Kopnitsky
ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-08
Decision Date1999-09-03

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