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510(k) K122398

RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS by Siemens Healthcare Diagnostics, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2012
Date Received
August 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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