510(k) K102772
K102772 is an FDA 510(k) premarket notification submitted by Siemens Heatlhcare Diagnostics, Inc. for the device "DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)". The FDA issued a decision of Substantially Equivalent on October 7, 2011. The device falls under product code OAV (Mycophenolic Acid Test System), a Class II device regulated under 21 CFR 862.3840. Siemens Heatlhcare Diagnostics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2011
- Date Received
- September 24, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mycophenolic Acid Test System
- Device Class
- Class II
- Regulation Number
- 862.3840
- Review Panel
- TX
- Submission Type
An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.