Clearance Summary
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST received FDA 510(k) clearance under submission number K033606, sponsored by Axis-Shield Diagnostics, 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 2004-01-30.
- Submission: K033606
- Applicant / Sponsor: Axis-Shield Diagnostics, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1117
- Decision date: 2004-01-30
Classification & Regulation
This clearance is catalogued under FDA product code NBC and 21 CFR 862.1117, within the Clinical Chemistry review panel as a Class II device.