THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS

Autoantibodies, Endomysial(tissue Transglutaminase)

THERATEST LABORATORIES, INC.

The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for Theratest El-ttg Iga/igg And Theratest El-glia Iga/igg Test Systems.

Pre-market Notification Details

Device IDK071692
510k NumberK071692
Device Name:THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard,  IL  60148
ContactMarius Teodorescu
CorrespondentMarius Teodorescu
THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard,  IL  60148
Product CodeMVM  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-20
Decision Date2007-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00854473003224 K071692 000
00854473003217 K071692 000

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