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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 K990928
Device Name LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
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
DIE  
Date Received03/19/1999
Decision Date 04/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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