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510(k) K113216

RAPIDPOINT 500 BLOOD GAS ANALYER by Siemens Healthcare Diagnostics — Product Code KHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2012
Date Received
November 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Lactic, Enzymatic Method
Device Class
Class I
Regulation Number
862.1450
Review Panel
CH
Submission Type

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