Clearance Summary
SUPERFLAB received FDA 510(k) clearance under submission number K812893, sponsored by Mick Radio-Nuclear Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1981-12-08.
- Submission: K812893
- Applicant / Sponsor: Mick Radio-Nuclear Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1370
- Decision date: 1981-12-08
Classification & Regulation
This clearance is catalogued under FDA product code IYP and 21 CFR 892.1370, within the Radiology review panel as a Class I device.