ANTI-RNP MICROASSAY

Extractable Antinuclear Antibody, Antigen And Control

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK901073
510k NumberK901073
Device Name:ANTI-RNP MICROASSAY
ClassificationExtractable Antinuclear Antibody, Antigen And 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 CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-08
Decision Date1990-03-19

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