OYA · P2psa
· Class 3
Overview
| Product Code | OYA |
|---|---|
| Device Name | P2psa |
| Device Class | Class 3 |
| Review Panel |
Identification
Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P090026 | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | Jun 14, 2012 | APPR |
Top Applicants
- Beckman Coulter, Inc. — 1 clearance
