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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K020878
Device Name LYPHOCHEK HEMOSTASIS, MODELS 798, 799
Applicant
Bio-Rad
9500 Jeronimo Rd.
Ivrvine,  CA  92618
Applicant Contact MARIA ZEBALLOS
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Ivrvine,  CA  92618
Correspondent Contact MARIA ZEBALLOS
Regulation Number864.5425
Classification Product Code
GGC  
Date Received03/18/2002
Decision Date 04/15/2002
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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