Clearance Summary
KONE CALCIUM TEST received FDA 510(k) clearance under submission number K880242, sponsored by The Rupp & Bowman Co.. 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 1988-03-15.
- Submission: K880242
- Applicant / Sponsor: The Rupp & Bowman Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1145
- Decision date: 1988-03-15
Classification & Regulation
This clearance is catalogued under FDA product code CJY and 21 CFR 862.1145, within the Clinical Chemistry review panel as a Class II device.