OWM · Class II · 21 CFR 866.6040

FDA Product Code OWM: Prostate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

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.

1
Total
1
Cleared
510d
Avg days
2011
Since

FDA 510(k) Cleared Prostate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers Devices (Product Code OWM)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OWM - Regulatory Context