Clearance Summary
I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS received FDA 510(k) clearance under submission number K945522, sponsored by Beckman-Diagnostic Systems Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1994-12-12.
- Submission: K945522
- Applicant / Sponsor: Beckman-Diagnostic Systems Group
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 1994-12-12
Classification & Regulation
This clearance is catalogued under FDA product code DFT and 21 CFR 866.5550, within the Immunology review panel as a Class II device.