OWM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6040
- Medical specialty
- Immunology
- FDA definition
- Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer.
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| Record | Firm | Date |
|---|---|---|
| NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY (K101185) | Iris Molecular Diagnostics | 2011-09-20 |
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Every clearance here is in the API, with alerts when new ones post.