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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 K033387
Device Name QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
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 Number862.1660
Classification Product Code
JJY  
Date Received10/23/2003
Decision Date 12/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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