Clearance Summary
ISO-DATA 500 SERIES GAMMA COUNTER received FDA 510(k) clearance under submission number K872430, sponsored by Iso-Data, 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 1987-08-21.
- Submission: K872430
- Applicant / Sponsor: Iso-Data, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2320
- Decision date: 1987-08-21
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.