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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K093357
Device Name DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
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 Number862.1150
Classification Product Code
JIT  
Date Received10/28/2009
Decision Date 06/24/2010
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
Predetermined Change
Control Plan Authorized		 No
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