Clearance Summary
VERSABLOT received FDA 510(k) clearance under submission number K884258, sponsored by American Bionetics, 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 1988-12-14.
- Submission: K884258
- Applicant / Sponsor: American Bionetics, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3800
- Decision date: 1988-12-14
Classification & Regulation
This clearance is catalogued under FDA product code KPA and 21 CFR 864.3800, within the Pathology review panel as a Class I device.