Clearance Summary
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 received FDA 510(k) clearance under submission number K853144, sponsored by Preco, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1985-10-16.
- Submission: K853144
- Applicant / Sponsor: Preco, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5640
- Decision date: 1985-10-16
Classification & Regulation
This clearance is catalogued under FDA product code KTN and 21 CFR 866.5640, within the Immunology review panel as a Class II device.