Clearance Summary
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES received FDA 510(k) clearance under submission number K980646, sponsored by Instrumentation Laboratory CO. 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 1998-05-06.
- Submission: K980646
- Applicant / Sponsor: Instrumentation Laboratory CO
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1113
- Decision date: 1998-05-06
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.