Rockwell Medical, Inc
FDA Regulatory Profile
Rockwell Medical, Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 21 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1869-2018, Class II) was initiated on April 7, 2018. Its most recent 510(k) clearance was granted on October 20, 2016.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 21
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1869-2018 | Class II | DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in ac | April 7, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160847 | Rockwell Medical CitraPure Acid Concetrate | October 20, 2016 |