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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K092849
Device Name BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
Applicant
Epocal, Inc.
2060 Walkley Rd.
Ottawa,  CA K1G-3P5
Applicant Contact ROY LAYER
Correspondent
Epocal, Inc.
2060 Walkley Rd.
Ottawa,  CA K1G-3P5
Correspondent Contact ROY LAYER
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGA   CHL   GIO   JFP   JGS  
JPI  
Date Received09/16/2009
Decision Date 03/30/2010
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
Predetermined Change
Control Plan Authorized		 No
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