Clearance Summary
ISOPURE LC SYSTEM received FDA 510(k) clearance under submission number K862178, sponsored by The Perkin-Elmer Corp.. 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 1986-07-14.
- Submission: K862178
- Applicant / Sponsor: The Perkin-Elmer Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1986-07-14
Classification & Regulation
This clearance is catalogued under FDA product code LDM and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.