ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA

Epstein-barr Virus, Other

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-ebv Ea Igg Elisa.

Pre-market Notification Details

Device IDK981120
510k NumberK981120
Device Name:ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
ClassificationEpstein-barr Virus, Other
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 CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-27
Decision Date1998-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840239027962 K981120 000
04048474027969 K981120 000

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