Clearance Summary
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL received FDA 510(k) clearance under submission number K182474, sponsored by Biosystems S.A.. 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 2019-05-02.
- Submission: K182474
- Applicant / Sponsor: Biosystems S.A.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1070
- Decision date: 2019-05-02
Classification & Regulation
This clearance is catalogued under FDA product code JFJ and 21 CFR 862.1070, within the Clinical Chemistry review panel as a Class II device.