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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cryptosporidium Spp.
510(k) Number K171078
Device Name TRI-COMBO PARASITE SCREEN
Applicant
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24060 -6358
Applicant Contact Donna T. Link
Correspondent
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24060 -6358
Correspondent Contact Donna T. Link
Regulation Number866.3220
Classification Product Code
MHJ  
Subsequent Product Codes
KHW   MHI  
Date Received04/11/2017
Decision Date 07/10/2017
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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