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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 K103836
Device Name ENZYME II CALIBRATOR
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC
500 GBC DRIVE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact ANNA MARIE KATH ENNIS
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS INC
500 GBC DRIVE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact ANNA MARIE KATH ENNIS
Regulation Number862.1150
Classification Product Code
JIT  
Date Received12/30/2010
Decision Date 02/16/2011
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
Recalls CDRH Recalls
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