ANTI-DNA MICROASSAY

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK863717
510k NumberK863717
Device Name:ANTI-DNA MICROASSAY
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactKiefer, Phd
CorrespondentKiefer, Phd
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-23
Decision Date1986-10-24

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