Clearance Summary
GESTE FOLLOW KIT DETERM. OF HPL received FDA 510(k) clearance under submission number K802454, 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 1980-11-12.
- Submission: K802454
- Applicant / Sponsor: Syn-Kit, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1585
- Decision date: 1980-11-12
Classification & Regulation
This clearance is catalogued under FDA product code JMF and 21 CFR 862.1585, within the Clinical Chemistry review panel as a Class II device.