Clearance Summary
COMBI-SCREEN, MODELS 10SL AND 11SL received FDA 510(k) clearance under submission number K023885, sponsored by Analyticon Biotechnologies AG. 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 2003-10-21.
- Submission: K023885
- Applicant / Sponsor: Analyticon Biotechnologies AG
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 2003-10-21
Classification & Regulation
This clearance is catalogued under FDA product code JIL and 21 CFR 862.1340, within the Clinical Chemistry review panel as a Class II device.