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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 K070848
Device Name LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
Applicant
Bio-Rad, Diagnostics Grp.
9500 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact ELIZABETH PLATT
Correspondent
Bio-Rad, Diagnostics Grp.
9500 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJW  
Date Received03/28/2007
Decision Date 04/25/2007
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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