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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Giardia Spp.
510(k) Number K103673
Device Name GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
Applicant
Techlab Inc., Corporate Research Center
2001 Kraft Dr.
Blacksburg,  VA  24060
Applicant Contact DONNA T LINK
Correspondent
Techlab Inc., Corporate Research Center
2001 Kraft Dr.
Blacksburg,  VA  24060
Correspondent Contact DONNA T LINK
Regulation Number866.3220
Classification Product Code
MHI  
Subsequent Product Code
MHJ  
Date Received12/16/2010
Decision Date 08/18/2011
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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