Diagnos Inc
FDA Regulatory Profile
Diagnos Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0826-2022, Class II) was initiated on January 11, 2022. Its most recent 510(k) clearance was granted on July 14, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0826-2022 | Class II | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 | January 11, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K110869 | CARA | July 14, 2011 |