ANTINUCLEAR ANTIBODY SCREEN FLOURESC

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

IMMUNO-PRODUCTS INDUSTRIES

The following data is part of a premarket notification filed by Immuno-products Industries with the FDA for Antinuclear Antibody Screen Flouresc.

Pre-market Notification Details

Device IDK821576
510k NumberK821576
Device Name:ANTINUCLEAR ANTIBODY SCREEN FLOURESC
ClassificationMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Applicant IMMUNO-PRODUCTS INDUSTRIES 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 Received1982-05-28
Decision Date1982-06-10

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