Clearance Summary
BILIRUBIN PLUS/PEDIATRIC CONTROLS received FDA 510(k) clearance under submission number K943290, sponsored by Medi-Tech, 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 1994-09-14.
- Submission: K943290
- Applicant / Sponsor: Medi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1994-09-14
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.