IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Immunop. Antimitochondrial Antibody Kit.

Pre-market Notification Details

Device IDK800229
510k NumberK800229
Device Name:IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
ClassificationAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDBM  
CFR Regulation Number866.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-02-05
Decision Date1980-02-21

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