Clinical Diagnostic Systems
FDA Regulatory Profile
Clinical Diagnostic Systems 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-1322-2018, Class III) was initiated on January 11, 2018. Its most recent 510(k) clearance was granted on January 17, 1995.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1322-2018 | Class III | VITROS Immunodiagnostic Products TSH Reagent Pack | January 11, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K946090 | KODAK EKTACCHEM 950IRC ANALYZER | January 17, 1995 |