MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT

Apolipoproteins

MEDIX BIOTECH, INC.

The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Medix Biotech Apolipoprotein A-i Test Kit.

Pre-market Notification Details

Device IDK872794
510k NumberK872794
Device Name:MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
ClassificationApolipoproteins
Applicant MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City,  CA  94404
ContactJohn J Huang
CorrespondentJohn J Huang
MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City,  CA  94404
Product CodeMSJ  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-14
Decision Date1987-09-23

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