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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 BEACH,  CA  90278 -1205
Applicant Contact GEBHARD NEYER
Correspondent
QUANTIMETRIX CORP.
2005 MANHATTAN BEACH BLVD.
REDONDO BEACH,  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
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