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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 K010605
Device Name ATLAST DATA MANAGEMENT SOFTWARE (DMS)
Applicant
AMIRA MEDICAL, INC.
4742 SCOTTS VALLEY DR.
SCOTTS VALLEY,  CA  95066
Applicant Contact NINA PELED
Correspondent
AMIRA MEDICAL, INC.
4742 SCOTTS VALLEY DR.
SCOTTS VALLEY,  CA  95066
Correspondent Contact NINA PELED
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
JQP  
Date Received02/28/2001
Decision Date 05/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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