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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
510(k) Number K051927
Device Name TECHLAB ASCA-CHEK
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 Number866.5785
Classification Product Code
NBT  
Date Received07/18/2005
Decision Date 04/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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