ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM

System, Test, Anticardiolipin Immunological

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Anti-cardiolipin Igm Test System.

Pre-market Notification Details

Device IDK981021
510k NumberK981021
Device Name:ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
ContactMark J Kopnitsky
CorrespondentMark J Kopnitsky
ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-19
Decision Date1998-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840239027894 K981021 000
04048474027891 K981021 000

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