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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K031231
Device Name LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
Applicant
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact ELIZABETH PLATT
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJW  
Date Received04/18/2003
Decision Date 06/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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