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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 K861970
Device Name LYPHOCHEK URINE TOXICOLOGY CONTROL
Applicant
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Applicant Contact FRANK MATARRESE
Correspondent
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Correspondent Contact FRANK MATARRESE
Regulation Number862.3280
Classification Product Code
DIF  
Date Received05/21/1986
Decision Date 08/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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