Clearance Summary
AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT received FDA 510(k) clearance under submission number K855034, sponsored by Bartels Immunodiagnostic Supplies, 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 1986-03-11.
- Submission: K855034
- Applicant / Sponsor: Bartels Immunodiagnostic Supplies, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4400
- Decision date: 1986-03-11
Classification & Regulation
This clearance is catalogued under FDA product code LIJ and 21 CFR 864.4400, within the Pathology review panel as a Class I device.