Clearance Summary
BN PROSPEC SYSTEM received FDA 510(k) clearance under submission number K001647, sponsored by Dade Behring, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2000-09-26.
- Submission: K001647
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4540
- Decision date: 2000-09-26
Classification & Regulation
This clearance is catalogued under FDA product code JZW and 21 CFR 866.4540, within the Immunology review panel as a Class I device.