Clearance Summary
ACID PHOSPHATASE REAGENT SET received FDA 510(k) clearance under submission number K821526, 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 1982-06-10.
- Submission: K821526
- Applicant / Sponsor: Anco Medical Reagents & Assoc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1020
- Decision date: 1982-06-10
Classification & Regulation
This clearance is catalogued under FDA product code CKE and 21 CFR 862.1020, within the Clinical Chemistry review panel as a Class II device.