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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 K021411
Device Name LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
Applicant
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618 -2017
Applicant Contact ELIZABETH PLATE
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618 -2017
Correspondent Contact ELIZABETH PLATE
Regulation Number862.3280
Classification Product Code
DIF  
Date Received05/03/2002
Decision Date 05/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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