VARICELLA-ZOSTER(IGG) IFA TEST

Antigen, Cf, (including Cf Control), Varicella-zoster

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Varicella-zoster(igg) Ifa Test.

Pre-market Notification Details

Device IDK841434
510k NumberK841434
Device Name:VARICELLA-ZOSTER(IGG) IFA TEST
ClassificationAntigen, Cf, (including Cf Control), Varicella-zoster
Applicant ZEUS SCIENTIFIC, INC. ST. JOHN & ELIZABETH STREETS Raritan ,  NJ  08869 -
ContactDavid A Wall
CorrespondentDavid A Wall
ZEUS SCIENTIFIC, INC. ST. JOHN & ELIZABETH STREETS Raritan ,  NJ  08869 -
Product CodeGQW  
CFR Regulation Number866.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-06
Decision Date1985-04-19

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