ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB

Antinuclear Antibody, 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 Tissue Culture Sub.

Pre-market Notification Details

Device IDK831054
510k NumberK831054
Device Name:ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant IMMUNO-PRODUCTS INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-01
Decision Date1983-04-27

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