Clearance Summary
SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER received FDA 510(k) clearance under submission number K850708, sponsored by Bausch & Lomb, 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 1985-03-11.
- Submission: K850708
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1985-03-11
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.