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510(k) K083339

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) by Siemens Healthcare Diagnostics, Inc. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2009
Date Received
November 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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