Clearance Summary
INSTANT-VIEW TROPONIN I TEST received FDA 510(k) clearance under submission number K042227, sponsored by Alfa Scientific Designs, Inc.. 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 2004-11-19.
- Submission: K042227
- Applicant / Sponsor: Alfa Scientific Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2004-11-19
Classification & Regulation
This clearance is catalogued under FDA product code MMI and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.