Clearance Summary
NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B received FDA 510(k) clearance under submission number K071649, sponsored by Wallac OY. 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 2008-08-07.
- Submission: K071649
- Applicant / Sponsor: Wallac OY
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1310
- Decision date: 2008-08-07
Classification & Regulation
This clearance is catalogued under FDA product code JIA and 21 CFR 862.1310, within the Clinical Chemistry review panel as a Class I device.