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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 K965171
Device Name LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
Applicant
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM,  CA  92806
Applicant Contact ELIZABETH PLATT
Correspondent
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM,  CA  92806
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/24/1996
Decision Date 01/13/1997
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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