Orgentec Diagnostika GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K100499 | ORGENTEC RHEUMATOID FACTOR EIA | October 27, 2010 |
| K092399 | ANTI-MUTATED CITRULLINATED VIMENTIN EIA | July 1, 2010 |
| K030929 | ANA DETECT | May 2, 2003 |