Clearance Summary
GOT ISOENZYME ASSAY EIKEN KIT received FDA 510(k) clearance under submission number K802447, sponsored by Syn-Kit, Inc.. 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 1981-04-17.
- Submission: K802447
- Applicant / Sponsor: Syn-Kit, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1100
- Decision date: 1981-04-17
Classification & Regulation
This clearance is catalogued under FDA product code CIT and 21 CFR 862.1100, within the Clinical Chemistry review panel as a Class II device.