Clearance Summary
MICROLYTE 7 received FDA 510(k) clearance under submission number K880973, 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 1988-09-07.
- Submission: K880973
- 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: 1988-09-07
Classification & Regulation
This clearance is catalogued under FDA product code JFP and 21 CFR 862.1145, within the Clinical Chemistry review panel as a Class II device.