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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Lactic, Enzymatic Method
510(k) Number K093297
Device Name EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
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 Number862.1450
Classification Product Code
KHP  
Date Received10/21/2009
Decision Date 06/09/2010
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
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