THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM

Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for The Aptus (automated) Application Of The Vzv Igg Elisa Test System.

Pre-market Notification Details

Device IDK984181
510k NumberK984181
Device Name:THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
ClassificationEnzyme Linked Immunoabsorbent Assay, Varicella-zoster
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 CodeLFY  
CFR Regulation Number866.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-23
Decision Date1999-01-22

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