Clearance Summary
AMYLASE EPS REAGENT received FDA 510(k) clearance under submission number K070064, sponsored by Thermo Fisher Scientific. 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 2007-05-22.
- Submission: K070064
- Applicant / Sponsor: Thermo Fisher Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1070
- Decision date: 2007-05-22
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.