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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K081294
Device Name ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
Applicant
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact PHILIP LIU
Correspondent
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact PHILIP LIU
Regulation Number866.5270
Classification Product Code
NQD  
Subsequent Product Code
JIX  
Date Received05/07/2008
Decision Date 07/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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