Mitsubishi Kagaku Iatron
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K081360 | PATHFAST CK-MB-II, PATHFAST MYO-II | August 17, 2009 |
| K072288 | PATHFAST D-DIMER | May 6, 2009 |
| K083412 | PATHFAST HSCRP | March 9, 2009 |
| K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS | February 5, 2008 |