Clearance Summary
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 received FDA 510(k) clearance under submission number K021622, sponsored by Hill-Rom Air-Shields. 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 2003-04-01.
- Submission: K021622
- Applicant / Sponsor: Hill-Rom Air-Shields
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1113
- Decision date: 2003-04-01
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.