Clearance Summary
ELX808 AUTOMATED MICROPLATE READERS received FDA 510(k) clearance under submission number K953710, sponsored by Bio-Tek Instruments, 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 1995-10-25.
- Submission: K953710
- Applicant / Sponsor: Bio-Tek Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1995-10-25
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.