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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K181525
Device Name INNOVANCE Free PS Ag
Applicant
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring Strasse 76
Marburg,  DE 35041
Applicant Contact Petra Dissmann
Correspondent
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring Strasse 76
Marburg,  DE 35041
Correspondent Contact Petra Dissmann
Regulation Number864.7290
Classification Product Code
GGP  
Date Received06/11/2018
Decision Date 09/07/2018
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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