DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM

Antibodies, Gliadin

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK012795
510k NumberK012795
Device Name:DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
ClassificationAntibodies, Gliadin
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLynne Stirling
CorrespondentLynne Stirling
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeMST  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-21
Decision Date2001-09-28
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.