Clearance Summary
LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR received FDA 510(k) clearance under submission number K010030, sponsored by Synergent Biochem Inc.-Clinical Controls Div.. 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 2001-02-14.
- Submission: K010030
- Applicant / Sponsor: Synergent Biochem Inc.-Clinical Controls Div.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2001-02-14
Classification & Regulation
This clearance is catalogued under FDA product code JIX and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.