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510(k) K092849

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER by Epocal, Inc. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2010
Date Received
September 16, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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