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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 K982076
Device Name AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
Applicant
AMIRA MEDICAL, INC.
4742 SCOTTS VALLEY DR.
SCOTTS VALLEY,  CA  95066
Applicant Contact DAVID A HASKER
Correspondent
AMIRA MEDICAL, INC.
4742 SCOTTS VALLEY DR.
SCOTTS VALLEY,  CA  95066
Correspondent Contact DAVID A HASKER
Regulation Number862.1345
Classification Product Code
CGA  
Date Received06/12/1998
Decision Date 12/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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