Clearance Summary
VIGIL PRX CHEMISTRY CONTROL received FDA 510(k) clearance under submission number K936184, sponsored by Beckman-Diagnostic Systems Group. 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 1994-04-15.
- Submission: K936184
- Applicant / Sponsor: Beckman-Diagnostic Systems Group
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1994-04-15
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.