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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 K052932
Device Name CRYPTOSPORIDIUM II
Applicant
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24060
Applicant Contact DAVID M LYERLY
Correspondent
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24060
Correspondent Contact DAVID M LYERLY
Regulation Number866.3220
Classification Product Code
MHJ  
Date Received10/19/2005
Decision Date 11/04/2005
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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