ANTISMOOTH MUSCLE ANTIBODY TEST SYS

Antismooth Muscle 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 Antismooth Muscle Antibody Test Sys.

Pre-market Notification Details

Device IDK810983
510k NumberK810983
Device Name:ANTISMOOTH MUSCLE ANTIBODY TEST SYS
ClassificationAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant IMMUNO-PRODUCTS INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDBE  
CFR Regulation Number866.5120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-13
Decision Date1981-05-01

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