510(k) K063520
K063520 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on February 16, 2007. The device falls under product code OAV (Mycophenolic Acid Test System), a Class II device regulated under 21 CFR 862.3840. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2007
- Date Received
- November 21, 2006
- 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.