Clearance Summary
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) received FDA 510(k) clearance under submission number K053597, sponsored by I-Stat Corporation. 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 2006-07-21.
- Submission: K053597
- Applicant / Sponsor: I-Stat Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1117
- Decision date: 2006-07-21
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.