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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K032017
Device Name LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
Applicant
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact MARIA ZEBALLOS
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact MARIA ZEBALLOS
Regulation Number864.5425
Classification Product Code
GGN  
Date Received06/30/2003
Decision Date 08/08/2003
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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