Clearance Summary
A O HISTOSTAT EMBEDDING CTR #8030,32,34 received FDA 510(k) clearance under submission number K821831, sponsored by Warner-Lambert Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1982-07-13.
- Submission: K821831
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1982-07-13
Classification & Regulation
This clearance is catalogued under FDA product code IDS and 21 CFR 864.3010, within the Pathology review panel as a Class I device.