Clearance Summary
OCTEIA IGF-1 KIT received FDA 510(k) clearance under submission number K950510, sponsored by Immunodiagnostic Systems , Ltd.. 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 1995-04-05.
- Submission: K950510
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1370
- Decision date: 1995-04-05
Classification & Regulation
This clearance is catalogued under FDA product code CFL and 21 CFR 862.1370, within the Clinical Chemistry review panel as a Class I device.