CMV MICROASSAY

Antiserum, Cf, Cytomegalovirus

DIAMEDIX CORP.

The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Cmv Microassay.

Pre-market Notification Details

Device IDK864420
510k NumberK864420
Device Name:CMV MICROASSAY
ClassificationAntiserum, Cf, Cytomegalovirus
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactDavid J Kiefer,phd
CorrespondentDavid J Kiefer,phd
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeGQI  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-10
Decision Date1987-02-02

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