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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K883247
Device Name LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL
Applicant
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Applicant Contact ERNEST S JOHNSON
Correspondent
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Correspondent Contact ERNEST S JOHNSON
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/02/1988
Decision Date 09/13/1988
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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