Clearance Summary
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 received FDA 510(k) clearance under submission number K871329, sponsored by Em Diagnostic Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 1987-05-12.
- Submission: K871329
- Applicant / Sponsor: Em Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3450
- Decision date: 1987-05-12
Classification & Regulation
This clearance is catalogued under FDA product code LCD and 21 CFR 862.3450, within the Clinical Toxicology review panel as a Class II device.