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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose oxidase, glucose
510(k) Number K090109
Device Name BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
Applicant
EPOCAL, INC.
2060 WALKLEY RD.
OTTAWA, ONTARIO,  CA K1G-3P5
Applicant Contact ROY LAYER
Correspondent
EPOCAL, INC.
2060 WALKLEY RD.
OTTAWA, ONTARIO,  CA K1G-3P5
Correspondent Contact ROY LAYER
Regulation Number862.1345
Classification Product Code
CGA  
Date Received01/15/2009
Decision Date 06/24/2009
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
Recalls CDRH Recalls
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