ATHENA MULTI-LYTE HSV 1 & 2 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 Athena Multi-lyte Hsv 1 & 2 Igg Test System.

Pre-market Notification Details

Device IDK072178
510k NumberK072178
Device Name:ATHENA MULTI-LYTE HSV 1 & 2 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 Received2007-08-06
Decision Date2008-05-30
Summary:summary

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