EBV-VCA IGG ELISA TEST SYSTEM

Antigen, Ebv, Capsid

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ebv-vca Igg Elisa Test System.

Pre-market Notification Details

Device IDK924091
510k NumberK924091
Device Name:EBV-VCA IGG ELISA TEST SYSTEM
ClassificationAntigen, Ebv, Capsid
Applicant ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan,  NJ  08869
ContactJoseph A Rosebrock
CorrespondentJoseph A Rosebrock
ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan,  NJ  08869
Product CodeMCD  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-13
Decision Date1993-01-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840239027931 K924091 000
04048474027938 K924091 000

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