ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA 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 Zeus Scientific, Inc. Athena Multi-lyte Ana Test System.

Pre-market Notification Details

Device IDK011244
510k NumberK011244
Device Name:ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-23
Decision Date2001-12-10

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