Clearance Summary
LIQUIPETTE received FDA 510(k) clearance under submission number K831079, sponsored by The Kendall Company Div. of Tyco Healthcare Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1983-04-28.
- Submission: K831079
- Applicant / Sponsor: The Kendall Company Div. of Tyco Healthcare Group
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6160
- Decision date: 1983-04-28
Classification & Regulation
This clearance is catalogued under FDA product code GJG and 21 CFR 864.6160, within the Hematology review panel as a Class I device.