LYME IGM MICROASSAY

Reagent, Borrelia Serological Reagent

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK900572
510k NumberK900572
Device Name:LYME IGM MICROASSAY
ClassificationReagent, Borrelia Serological Reagent
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLin, Phd
CorrespondentLin, Phd
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-07
Decision Date1990-05-02

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