PROSTATE-63 CANCER DIAGNOSTIC TEST
FDA 510(k) clearance K050063 · decided 2005-02-09
Clearance details
- K-number
- K050063
- Device name
- PROSTATE-63 CANCER DIAGNOSTIC TEST
- Applicant
- Asymmetrx
- Decision
- Substantially Equivalent
- Date received
- 2005-01-11
- Decision date
- 2005-02-09
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- NTR
- Device class
- 1
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Amston, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.