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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K113177
Device Name COMPLETE D 25-OH VITAMIN D CONTROL
Applicant
QUANTIMETRIX CORP.
2005 MANHATTAN BEACH BLVD.
REDONDO BEACH,  CA  90278 -1205
Applicant Contact KALYNA SNYLYK
Correspondent
QUANTIMETRIX CORP.
2005 MANHATTAN BEACH BLVD.
REDONDO BEACH,  CA  90278 -1205
Correspondent Contact KALYNA SNYLYK
Regulation Number862.1660
Classification Product Code
JJX  
Date Received10/28/2011
Decision Date 05/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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