CMV IGM MICROASSAY

Antibody Igm,if, Cytomegalovirus Virus

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK871832
510k NumberK871832
Device Name:CMV IGM MICROASSAY
ClassificationAntibody Igm,if, Cytomegalovirus Virus
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactKiefer, Phd
CorrespondentKiefer, Phd
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeLKQ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-11
Decision Date1987-08-07

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