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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K895905
Device Name LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact TREVOR WALL
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact TREVOR WALL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/06/1989
Decision Date 01/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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