Clearance Summary
CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC received FDA 510(k) clearance under submission number K790556, sponsored by Calbiochem-Behring 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 1979-05-07.
- Submission: K790556
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 1979-05-07
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.