Clearance Summary
AD PERFECT received FDA 510(k) clearance under submission number K940768, sponsored by Chimera Research & Chemical, 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 1995-02-17.
- Submission: K940768
- Applicant / Sponsor: Chimera Research & Chemical, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1995-02-17
Classification & Regulation
This clearance is catalogued under FDA product code IFT and 21 CFR 864.4010, within the Pathology review panel as a Class I device.