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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 K124009
Device Name MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
Applicant
DIAMOND DIAGNOSTICS, INC.
333 FISKE ST.
HOLLISTON,  MA  01746
Applicant Contact KATHY CRUZ
Correspondent
DIAMOND DIAGNOSTICS, INC.
333 FISKE ST.
HOLLISTON,  MA  01746
Correspondent Contact KATHY CRUZ
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/27/2012
Decision Date 04/17/2013
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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