ATHENA MULTI-LYTE ANA-II TEST SYSTEM

Antinuclear Antibody, Antigen, Control

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Athena Multi-lyte Ana-ii Test System.

Pre-market Notification Details

Device IDK042416
510k NumberK042416
Device Name:ATHENA MULTI-LYTE ANA-II TEST SYSTEM
ClassificationAntinuclear Antibody, Antigen, Control
Applicant ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan,  NJ  08869
ContactMark J Kopnitsky
CorrespondentMark J Kopnitsky
ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan,  NJ  08869
Product CodeLKJ  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-07
Decision Date2004-10-08

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