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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mycophenolic Acid Test System
510(k) Number K102772
Device Name DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
Applicant
Siemens Heatlhcare Diagnostics, Inc.
500 Gbc Dr., M/S 514
Newark,  DE  19714
Applicant Contact HELEN M LEE
Correspondent
Siemens Heatlhcare Diagnostics, Inc.
500 Gbc Dr., M/S 514
Newark,  DE  19714
Correspondent Contact HELEN M LEE
Regulation Number862.3840
Classification Product Code
OAV  
Subsequent Product Code
DLJ  
Date Received09/24/2010
Decision Date 10/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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