ZEUS ELISA HSV GC-I IGG TEST SYSTEM

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

ZEUS SCIENTIFIC, INC.

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

Pre-market Notification Details

Device IDK103363
510k NumberK103363
Device Name:ZEUS ELISA HSV GC-I IGG TEST SYSTEM
ClassificationEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Applicant ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
ContactEwa Nadolczak
CorrespondentEwa Nadolczak
ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
Product CodeMXJ  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-17
Decision Date2011-04-26

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