Clearance Summary
LAD MODEL 633 LUMINOMETER received FDA 510(k) clearance under submission number K882608, sponsored by Los Alamos Diagnostics. 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 1988-08-29.
- Submission: K882608
- Applicant / Sponsor: Los Alamos Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1988-08-29
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.