Clearance Summary
GEN-PROBE LUMINOMETER-LEADER 450 received FDA 510(k) clearance under submission number K905762, sponsored by Gen-Probe, Inc.. 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 1991-01-23.
- Submission: K905762
- Applicant / Sponsor: Gen-Probe, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1991-01-23
Classification & Regulation
This clearance is catalogued under FDA product code JJQ and 21 CFR 862.2300, within the Clinical Chemistry review panel as a Class I device.