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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K001758
Device Name DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
5300 ADOLFO RD.
CAMARILLO,  CA  93012
Applicant Contact SCOT D KINGHORN
Correspondent
MEDICAL ANALYSIS SYSTEMS, INC.
5300 ADOLFO RD.
CAMARILLO,  CA  93012
Correspondent Contact SCOT D KINGHORN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/09/2000
Decision Date 07/05/2000
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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