Qualisys Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K994419 | FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM | June 28, 2000 |
| K990234 | QUALISYS PSA IMMUNOASSAY | July 8, 1999 |