DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM

Anti-dna Antibody (enzyme-labeled), Antigen, Control

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK994424
510k NumberK994424
Device Name:DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
ClassificationAnti-dna Antibody (enzyme-labeled), Antigen, Control
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLynne Stirling
CorrespondentLynne Stirling
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeLRM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-30
Decision Date2000-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020372 K994424 000
B3507207000 K994424 000

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