FDA 510(k) Applications for Medical Device Product Code "OAV"
(Mycophenolic Acid Test System)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K063520 | Roche Diagnostics | ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS | 02/16/2007 |
| K102772 | SIEMENS HEATLHCARE DIAGNOSTICS INC | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) | 10/07/2011 |
| K081083 | Thermo Fisher Scientific | CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS | 12/19/2008 |
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