Clearance Summary
ULTRAZYME PLUS GPT received FDA 510(k) clearance under submission number K821882, sponsored by Harleco Diagnostics. 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 1982-07-14.
- Submission: K821882
- Applicant / Sponsor: Harleco Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1030
- Decision date: 1982-07-14
Classification & Regulation
This clearance is catalogued under FDA product code CKA and 21 CFR 862.1030, within the Clinical Chemistry review panel as a Class I device.