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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 K852414
Device Name LYPHOCHEK DRUG FREE SERUM(HUMAN)
Applicant
Bio-Rad
3726 E. Miraloma Ave.
Anaheim,  CA  92806
Applicant Contact TOM SANDOVAL
Correspondent
Bio-Rad
3726 E. Miraloma Ave.
Anaheim,  CA  92806
Correspondent Contact TOM SANDOVAL
Regulation Number862.3280
Classification Product Code
DIF  
Date Received06/06/1985
Decision Date 07/24/1985
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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