Clearance Summary
DIRECT ACU-SLIDE TEST received FDA 510(k) clearance under submission number K861212, sponsored by Cal-Tech Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1986-07-07.
- Submission: K861212
- Applicant / Sponsor: Cal-Tech Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1986-07-07
Classification & Regulation
This clearance is catalogued under FDA product code JHJ and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.