SHIGA TOXIN CHEK

Antigens, All Types, Escherichia Coli

TECHLAB INC., CORPORATE RESEARCH CENTER

The following data is part of a premarket notification filed by Techlab Inc., Corporate Research Center with the FDA for Shiga Toxin Chek.

Pre-market Notification Details

Device IDK121411
510k NumberK121411
Device Name:SHIGA TOXIN CHEK
ClassificationAntigens, All Types, Escherichia Coli
Applicant TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg,  VA  24060 -6358
ContactDonna T Link
CorrespondentDonna T Link
TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg,  VA  24060 -6358
Product CodeGMZ  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-11
Decision Date2012-10-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857031002417 K121411 000

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