ZEUS ELISA HSV GG-2 IGG TEST SYSTEM

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Elisa Hsv Gg-2 Igg Test System.

Pre-market Notification Details

Device IDK103603
510k NumberK103603
Device Name:ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
ClassificationEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
ContactEwa Nadolczak
CorrespondentEwa Nadolczak
ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
Product CodeMYF  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-08
Decision Date2011-05-20

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