PROSTATE-63 CANCER DIAGNOSTIC TEST— 510(k) K050063
Substantially EquivalentAsymmetrx
FDA 510(k) clearance K050063 for PROSTATE-63 CANCER DIAGNOSTIC TEST, Substantially Equivalent on 2005-02-09. Applicant: Asymmetrx. Device class: 1.
Clearance details
- Applicant
- Asymmetrx
- Product code
- Code NTR
- Device class
- Class 1
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amston, CT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.