Clearance Summary
MEDICOR QUALITY CONTROL BUFFER received FDA 510(k) clearance under submission number K791287, sponsored by Medicor USA , Ltd.. 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 1979-08-16.
- Submission: K791287
- Applicant / Sponsor: Medicor USA , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1979-08-16
Classification & Regulation
This clearance is catalogued under FDA product code JJS and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.