AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY

Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

CALBIOCHEM-BEHRING CORP.

The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Aft Tm System Antismooth Muscle Antibody.

Pre-market Notification Details

Device IDK800820
510k NumberK800820
Device Name:AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY
ClassificationAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant CALBIOCHEM-BEHRING CORP. 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 Received1980-04-11
Decision Date1980-04-24

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