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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K092113
Device Name STA - FREE PS CALIBRATOR
Applicant
DIAGNOSTICA STAGO, INC.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Applicant Contact UMBERTO V PARROTTA
Correspondent
DIAGNOSTICA STAGO, INC.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Correspondent Contact UMBERTO V PARROTTA
Regulation Number862.1150
Classification Product Code
JIX  
Date Received07/14/2009
Decision Date 11/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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