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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Campylobacter Spp.
510(k) Number K173219
Device Name CAMPYLOBACTER CHEK
Applicant
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24060
Applicant Contact Donna T. Link
Correspondent
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24060
Correspondent Contact Donna T. Link
Regulation Number866.3110
Classification Product Code
LQP  
Date Received10/03/2017
Decision Date 01/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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