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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K023991
Device Name CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
Applicant
PRECISION BIOLOGIC
900 WINDMILL RD., SUITE 100
DARTMOUTH, N.S.,  CA B3B 1P7
Applicant Contact STEPHEN L DUFF
Correspondent
PRECISION BIOLOGIC
900 WINDMILL RD., SUITE 100
DARTMOUTH, N.S.,  CA B3B 1P7
Correspondent Contact STEPHEN L DUFF
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received12/03/2002
Decision Date 04/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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