Clearance Summary
GOLD(AU 195) SPOT MARKER SOURCES received FDA 510(k) clearance under submission number K812235, sponsored by Amersham Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1981-09-09.
- Submission: K812235
- Applicant / Sponsor: Amersham Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1400
- Decision date: 1981-09-09
Classification & Regulation
This clearance is catalogued under FDA product code IXD and 21 CFR 892.1400, within the Radiology review panel as a Class I device.