Clearance Summary
LKB-BROMMA 2188 ULTROTOME NOVA received FDA 510(k) clearance under submission number K812158, 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 1981-09-16.
- Submission: K812158
- Applicant / Sponsor: Lkb Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1981-09-16
Classification & Regulation
This clearance is catalogued under FDA product code IDM and 21 CFR 864.3010, within the Pathology review panel as a Class I device.