Clearance Summary
GLYCOTEST II GLYHB ASSAY KIT received FDA 510(k) clearance under submission number K895661, sponsored by Pierce Chemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1989-12-07.
- Submission: K895661
- Applicant / Sponsor: Pierce Chemical Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 1989-12-07
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.