Clearance Summary
UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 received FDA 510(k) clearance under submission number K922770, sponsored by Leica, 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 1992-08-18.
- Submission: K922770
- Applicant / Sponsor: Leica, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1113
- Decision date: 1992-08-18
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.