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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 K191456
Device Name Campylobacter Quik Chek
Applicant
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24085
Applicant Contact Donna Link
Correspondent
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24085
Correspondent Contact Donna Link
Regulation Number866.3110
Classification Product Code
LQP  
Date Received05/31/2019
Decision Date 06/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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