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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzymatic method, creatinine
510(k) Number K070727
Device Name ADVIA CHEMISTRY ENZYMATIC CREATININE_2
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Applicant Contact PHILIP LIU
Correspondent
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact PHILIP LIU
Regulation Number862.1225
Classification Product Code
JFY  
Date Received03/15/2007
Decision Date 08/03/2007
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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