Panels › Clinical Toxicology › Product code OAV · Class 2
Mycophenolic Acid Test System
Regulation 862.3840
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OAV
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics | 1 | 0 |
| Siemens Heatlhcare Diagnostics, Inc. | 1 | 0 |
| Thermo Fisher Scientific | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2011 | K102772 | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) Siemens Heatlhcare Diagnostics, Inc. | OAV |
| Dec 19, 2008 | K081083 | CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS Thermo Fisher Scientific | OAV |
| Feb 16, 2007 | K063520 | ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS Roche Diagnostics | OAV |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.