Roche Diagnostics Corp.
FDA 510(k) & PMA Approved Devices — 2 products
Total Devices2
Categories2
Latest Approval2026-04-29
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| PMA | P990056 | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer | MTF | 2026-04-29 | View |
| PMA | P000027 | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | LTJ | 2026-04-29 | View |
No matching devices.