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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Partial Thromboplastin
510(k) Number K060284
Device Name CRYOCHECK CLOT APCR
Applicant
Precision Biologic, Inc.
900 Windmill Rd., Suite 100
Dartmouth, N.S.,  CA B3B 1P7
Applicant Contact STEPHEN L DUFF
Correspondent
Precision Biologic, Inc.
900 Windmill Rd., Suite 100
Dartmouth, N.S.,  CA B3B 1P7
Correspondent Contact STEPHEN L DUFF
Regulation Number864.7925
Classification Product Code
GGW  
Date Received02/03/2006
Decision Date 05/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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