Clearance Summary
YSI MODEL 23L LACTATE ANALYZER received FDA 510(k) clearance under submission number K822812, sponsored by Yellow Springs Instrument Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1982-12-13.
- Submission: K822812
- Applicant / Sponsor: Yellow Springs Instrument Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1982-12-13
Classification & Regulation
This clearance is catalogued under FDA product code HHP and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.