Clearance Summary
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER received FDA 510(k) clearance under submission number K010052, sponsored by Respironics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2001-03-19.
- Submission: K010052
- Applicant / Sponsor: Respironics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1113
- Decision date: 2001-03-19
Classification & Regulation
This clearance is catalogued under FDA product code MQM and 21 CFR 862.1113, within the Clinical Chemistry review panel as a Class I device.