Clearance Summary
MODIFIED MODEL 535(TM) LUMINOMETER received FDA 510(k) clearance under submission number K896117, 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 1989-11-30.
- Submission: K896117
- Applicant / Sponsor: Los Alamos Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1989-11-30
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.