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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 K021384
Device Name LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
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 Number862.3280
Classification Product Code
DIF  
Date Received05/02/2002
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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