Clearance Summary
GAMMA PHOTON GAMMA COUNTER received FDA 510(k) clearance under submission number K832210, sponsored by Medical & Scientific Designs, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1983-08-24.
- Submission: K832210
- Applicant / Sponsor: Medical & Scientific Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2320
- Decision date: 1983-08-24
Classification & Regulation
This clearance is catalogued under FDA product code JJJ and 21 CFR 862.2320, within the Clinical Chemistry review panel as a Class I device.