Clearance Summary
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 received FDA 510(k) clearance under submission number K874705, sponsored by Em Diagnostic Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1987-12-22.
- Submission: K874705
- Applicant / Sponsor: Em Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 1987-12-22
Classification & Regulation
This clearance is catalogued under FDA product code JEJ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.