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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 K853931
Device Name QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL
Applicant
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250
Applicant Contact LYNETTE SCHNEIDER
Correspondent
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250
Correspondent Contact LYNETTE SCHNEIDER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/24/1985
Decision Date 10/04/1985
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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