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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K081769
Device Name INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr., M/S 514
Newark,  DE  19702
Applicant Contact RADAMES RIESGO
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr., M/S 514
Newark,  DE  19702
Correspondent Contact RADAMES RIESGO
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received06/23/2008
Decision Date 05/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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