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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 K093492
Device Name MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR
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  
Subsequent Product Code
JIT  
Date Received11/10/2009
Decision Date 03/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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