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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K033366
Device Name LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455
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 Number862.3280
Classification Product Code
DIF  
Date Received10/21/2003
Decision Date 12/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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