ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS

System, Test, Anticardiolipin Immunological

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Scientific, Inc., Anti-cardiolipin Iga Elisa Reagents.

Pre-market Notification Details

Device IDK973196
510k NumberK973196
Device Name:ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
ClassificationSystem, Test, Anticardiolipin Immunological
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 CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-26
Decision Date1997-10-29

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