Clearance Summary
SGPT REAGENT SET received FDA 510(k) clearance under submission number K820491, 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 1982-03-11.
- Submission: K820491
- Applicant / Sponsor: Anco Medical Reagents & Assoc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1030
- Decision date: 1982-03-11
Classification & Regulation
This clearance is catalogued under FDA product code CKD and 21 CFR 862.1030, within the Clinical Chemistry review panel as a Class I device.