Clearance Summary
GEN-PROBE (R) LUMINOMETER - LEADER (TM) received FDA 510(k) clearance under submission number K872219, 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 1987-08-21.
- Submission: K872219
- Applicant / Sponsor: Gen-Probe, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1987-08-21
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.