IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA

Autoantibodies, Endomysial(tissue Transglutaminase)

IMMCO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Celiac Ttg Iga And Igg Antibody Elisa.

Pre-market Notification Details

Device IDK091520
510k NumberK091520
Device Name:IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo,  NY  14228 -2120
ContactKevin Lawson
CorrespondentKevin Lawson
IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo,  NY  14228 -2120
Product CodeMVM  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-22
Decision Date2010-03-10

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