Clearance Summary
MEDI-TEST COMBI 11 received FDA 510(k) clearance under submission number K991927, sponsored by Macherey-Nagel-Duren. 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 1999-09-17.
- Submission: K991927
- Applicant / Sponsor: Macherey-Nagel-Duren
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 1999-09-17
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.