Clearance Summary
QUANTECH CK-MB ASSAY received FDA 510(k) clearance under submission number K984433, sponsored by Quantech , Ltd.. 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 1999-11-01.
- Submission: K984433
- Applicant / Sponsor: Quantech , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1999-11-01
Classification & Regulation
This clearance is catalogued under FDA product code MYT and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.