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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Lipoproteins
510(k) Number K010337
Device Name LIPOPRINT SYSTEM, LDL SUBFRACTIONS
Applicant
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo,  CA  90278 -1205
Applicant Contact GEBHARD NEYER
Correspondent
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo,  CA  90278 -1205
Correspondent Contact GEBHARD NEYER
Regulation Number862.1475
Classification Product Code
JHO  
Subsequent Product Code
JJY  
Date Received02/05/2001
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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