Clearance Summary
PROSTATE-63 CANCER DIAGNOSTIC TEST received FDA 510(k) clearance under submission number K050063, sponsored by Asymmetrx. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-02-09.
- Submission: K050063
- Applicant / Sponsor: Asymmetrx
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1860
- Decision date: 2005-02-09
Classification & Regulation
This clearance is catalogued under FDA product code NTR and 21 CFR 864.1860, within the Hematology review panel as a Class I device.