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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 K011548
Device Name CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
5300 ADOLFO RD.
CAMARILLO,  CA  93012
Applicant Contact DARWIN RICHARDSON
Correspondent
MEDICAL ANALYSIS SYSTEMS, INC.
5300 ADOLFO RD.
CAMARILLO,  CA  93012
Correspondent Contact DARWIN RICHARDSON
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/18/2001
Decision Date 06/18/2001
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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