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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 K020610
Device Name LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
Applicant
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact Yvette Lloyd
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact Yvette Lloyd
Regulation Number862.3280
Classification Product Code
DIE  
Date Received02/25/2002
Decision Date 04/22/2002
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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