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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cresolphthalein complexone, calcium
510(k) Number K083339
Device Name DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
Applicant
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVENUE
TARRYTOWN,  NY  10509
Applicant Contact Lubomyr Shchur
Correspondent
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVENUE
TARRYTOWN,  NY  10509
Correspondent Contact Lubomyr Shchur
Regulation Number862.1145
Classification Product Code
CIC  
Subsequent Product Code
JJE  
Date Received11/12/2008
Decision Date 03/09/2009
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
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