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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, qualitative and quantitative factor deficiency
510(k) Number K043571
Device Name CRYOCHECK CLOT S
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 Number864.7290
Classification Product Code
GGP  
Date Received12/27/2004
Decision Date 03/18/2005
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
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