Clearance Summary
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 received FDA 510(k) clearance under submission number K880654, sponsored by American Research Products Co.. 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 1988-06-07.
- Submission: K880654
- Applicant / Sponsor: American Research Products Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 1988-06-07
Classification & Regulation
This clearance is catalogued under FDA product code JIW and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.