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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 K042717
Device Name MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
Applicant
Medical Analysis Systems, Inc.
5300 Adolfo Rd.
Camarillo,  CA  93012
Applicant Contact MARY THORSNESS
Correspondent
Medical Analysis Systems, Inc.
5300 Adolfo Rd.
Camarillo,  CA  93012
Correspondent Contact MARY THORSNESS
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/30/2004
Decision Date 11/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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