Clearance Summary
BILIRUBIN STANDARD-LYOPHILIZED received FDA 510(k) clearance under submission number K830469, sponsored by Dow Instruments & Reagents, 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 1983-03-24.
- Submission: K830469
- Applicant / Sponsor: Dow Instruments & Reagents, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 1983-03-24
Classification & Regulation
This clearance is catalogued under FDA product code JIT and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.