H. PYLORI QUIK CHEK

Helicobacter Pylori

TECHLAB, Inc.

The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for H. Pylori Quik Chek.

Pre-market Notification Details

Device IDK181379
510k NumberK181379
Device Name:H. PYLORI QUIK CHEK
ClassificationHelicobacter Pylori
Applicant TECHLAB, Inc. 2001 Kraft Drive Corporate Research Center Blacksburg,  VA  24060 -6358
ContactDonna T. Link
CorrespondentDonna T. Link
TECHLAB, Inc. 2001 Kraft Drive Corporate Research Center Blacksburg,  VA  24060 -6358
Product CodeLYR  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-24
Decision Date2018-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857031002516 K181379 000
00857031002493 K181379 000
00857031002561 K181379 000
00857031002622 K181379 000

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