DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

System, Test, Anticardiolipin Immunological

DIAMEDIX CORP.

The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-anti-cardiolipin Igg/igm Test System.

Pre-market Notification Details

Device IDK012449
510k NumberK012449
Device Name:DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLynne Stirling
CorrespondentLynne Stirling
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-01
Decision Date2001-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020235 K012449 000

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