THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

Extractable Antinuclear Antibody, Antigen And Control

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for The Aptus (automated) Application Of The Scl-70 Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The.

Pre-market Notification Details

Device IDK983423
510k NumberK983423
Device Name:THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
ClassificationExtractable Antinuclear Antibody, Antigen And Control
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 CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-29
Decision Date1998-11-18

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