Clearance Summary
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 received FDA 510(k) clearance under submission number K974053, sponsored by Diagnostic Chemicals , Ltd.. 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 1997-12-08.
- Submission: K974053
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1070
- Decision date: 1997-12-08
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.