ENA SCREEN ELISA TEST SYSTEM

Antinuclear Antibody (enzyme-labeled), Antigen, Controls

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ena Screen Elisa Test System.

Pre-market Notification Details

Device IDK941014
510k NumberK941014
Device Name:ENA SCREEN ELISA TEST SYSTEM
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
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 CodeLJM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-03
Decision Date1994-06-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840239027795 K941014 000
04048474027792 K941014 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.