Clearance Summary
6% ORTHO LOLIUDINE REAGENT IN GLACID ACI received FDA 510(k) clearance under submission number K810089, sponsored by Anco Medical Reagents & Assoc.. 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 1981-01-26.
- Submission: K810089
- Applicant / Sponsor: Anco Medical Reagents & Assoc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 1981-01-26
Classification & Regulation
This clearance is catalogued under FDA product code CGE and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.