CAMPYLOBACTER CHEK

Campylobacter Spp.

Techlab, Inc.

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

Pre-market Notification Details

Device IDK173219
510k NumberK173219
Device Name:CAMPYLOBACTER CHEK
ClassificationCampylobacter Spp.
Applicant Techlab, Inc. 2001 Kraft Drive Blacksburg,  VA  24060 -6358
ContactDonna T. Link
CorrespondentDonna T. Link
Techlab, Inc. 2001 Kraft Drive Blacksburg,  VA  24060 -6358
Product CodeLQP  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-03
Decision Date2018-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857031002462 K173219 000
00857031002486 K173219 000

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