Zeus IFA ANA HEp-2 Test System, Zeus DIFine

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Zeus Scientific, Inc.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Ifa Ana Hep-2 Test System, Zeus Difine.

Pre-market Notification Details

Device IDK201956
510k NumberK201956
Device Name:Zeus IFA ANA HEp-2 Test System, Zeus DIFine
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant Zeus Scientific, Inc. PO Box 38 Raritan,  NJ  08869
ContactMark J. Kopnitsky
CorrespondentMark J. Kopnitsky
Zeus Scientific, Inc. PO Box 38 Raritan,  NJ  08869
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-14
Decision Date2022-04-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.