Clearance Summary
APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 received FDA 510(k) clearance under submission number K853048, sponsored by Photec Diagnostics, 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 1985-08-28.
- Submission: K853048
- Applicant / Sponsor: Photec Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5580
- Decision date: 1985-08-28
Classification & Regulation
This clearance is catalogued under FDA product code DER and 21 CFR 866.5580, within the Immunology review panel as a Class II device.