Clearance Summary
OPUS PSA TEST SYSTEM received FDA 510(k) clearance under submission number K964595, sponsored by Behring Diagnostics, 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 1997-06-24.
- Submission: K964595
- Applicant / Sponsor: Behring Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1997-06-24
Classification & Regulation
This clearance is catalogued under FDA product code LTJ and 21 CFR 866.6010, within the Immunology review panel as a Class II device.