Eiken Chemical Co., Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191147 | OC-Auto SENSOR io iFOB Test | January 2, 2020 |
| K143325 | OC-Light S FIT | August 20, 2015 |
| K864342 | MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX | December 1, 1986 |
| K853391 | MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 | October 1, 1985 |