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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 K862185
Device Name LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
Applicant
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Applicant Contact FRANK MATARRESE
Correspondent
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Correspondent Contact FRANK MATARRESE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/09/1986
Decision Date 08/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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