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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 K022991
Device Name LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596
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 Number862.1660
Classification Product Code
JJY  
Date Received09/09/2002
Decision Date 09/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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