Clearance Summary
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 received FDA 510(k) clearance under submission number K961544, sponsored by Consolidated Technologies, 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 1996-09-24.
- Submission: K961544
- Applicant / Sponsor: Consolidated Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5700
- Decision date: 1996-09-24
Classification & Regulation
This clearance is catalogued under FDA product code DGR and 21 CFR 866.5700, within the Immunology review panel as a Class I device.