Clearance Summary
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT received FDA 510(k) clearance under submission number K982121, sponsored by Trace Scientific , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-09-17.
- Submission: K982121
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5090
- Decision date: 1998-09-17
Classification & Regulation
This clearance is catalogued under FDA product code DBM and 21 CFR 866.5090, within the Immunology review panel as a Class II device.