LYME DISEASE 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 Disease Microassay.

Pre-market Notification Details

Device IDK910899
510k NumberK910899
Device Name:LYME DISEASE MICROASSAY
ClassificationReagent, Borrelia Serological Reagent
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactTsue-ming Lin
CorrespondentTsue-ming Lin
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 Received1991-02-25
Decision Date1991-06-10

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