ANTI-SKIN ANTIBODY TEST SYSTEM

Multiple Autoantibodies, 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 Anti-skin Antibody Test System.

Pre-market Notification Details

Device IDK811261
510k NumberK811261
Device Name:ANTI-SKIN ANTIBODY TEST SYSTEM
ClassificationMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Applicant ZEUS SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDBL  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-06
Decision Date1981-08-12

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