Clearance Summary
LKB 2230 ROTARY ONE received FDA 510(k) clearance under submission number K843505, sponsored by Lkb Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1984-11-30.
- Submission: K843505
- Applicant / Sponsor: Lkb Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1984-11-30
Classification & Regulation
This clearance is catalogued under FDA product code IDO and 21 CFR 864.3010, within the Pathology review panel as a Class I device.