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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heavy Metals Control Materials
510(k) Number K891691
Device Name LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Applicant Contact LYNN C SHANTA
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Correspondent Contact LYNN C SHANTA
Regulation Number862.3280
Classification Product Code
DIE  
Date Received03/22/1989
Decision Date 12/19/1989
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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