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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K091303
Device Name LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
Applicant
Bio-Rad Laboratories
9500 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact SUZANNE S PARSONS
Correspondent
Bio-Rad Laboratories
9500 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact SUZANNE S PARSONS
Regulation Number864.8625
Classification Product Code
JPK  
Date Received05/04/2009
Decision Date 08/02/2010
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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