Clearance Summary
SINGLE VIAL LIPASE TEST KIT received FDA 510(k) clearance under submission number K802842, sponsored by Biodynamics 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 1980-12-18.
- Submission: K802842
- Applicant / Sponsor: Biodynamics Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1465
- Decision date: 1980-12-18
Classification & Regulation
This clearance is catalogued under FDA product code CHI and 21 CFR 862.1465, within the Clinical Chemistry review panel as a Class I device.