Clearance Summary
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 received FDA 510(k) clearance under submission number K073537, sponsored by Siemens Medical Solutions Diagnostics. 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 2008-06-27.
- Submission: K073537
- Applicant / Sponsor: Siemens Medical Solutions Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1113
- Decision date: 2008-06-27
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.