Clearance Summary
PH METER-130 (.001 PH) received FDA 510(k) clearance under submission number K760789, sponsored by Corning Medical & Scientific. 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 1976-11-16.
- Submission: K760789
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1976-11-16
Classification & Regulation
This clearance is catalogued under FDA product code JQY and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.