Clearance Summary
DILECTRON URINARY CONDUCTIVITY PROBE received FDA 510(k) clearance under submission number K891681, sponsored by Gyrus Medical , Ltd.. 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 1990-05-01.
- Submission: K891681
- Applicant / Sponsor: Gyrus Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2800
- Decision date: 1990-05-01
Classification & Regulation
This clearance is catalogued under FDA product code JRE and 21 CFR 862.2800, within the Clinical Chemistry review panel as a Class I device.