Clearance Summary
ENZYMATIC REAGENT FOR CHOLESTEROL MEAS received FDA 510(k) clearance under submission number K781013, sponsored by Coulter Electronics, 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 1978-07-28.
- Submission: K781013
- Applicant / Sponsor: Coulter Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 1978-07-28
Classification & Regulation
This clearance is catalogued under FDA product code CHH and 21 CFR 862.1175, within the Clinical Chemistry review panel as a Class I device.