Clearance Summary
MODIFICATION TO ALPHA DX SYSTEM received FDA 510(k) clearance under submission number K013118, sponsored by First Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2001-10-15.
- Submission: K013118
- Applicant / Sponsor: First Medical, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2001-10-15
Classification & Regulation
This clearance is catalogued under FDA product code JHX and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.