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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K991075
Device Name ATLAST GLUCOSE CONTROL SOLUTION
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 Number862.1660
Classification Product Code
JJX  
Date Received03/31/1999
Decision Date 05/10/1999
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
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