Clearance Summary
AUTODELFIA NEONATAL HTSH L KIT (B077-112) received FDA 510(k) clearance under submission number K973276, sponsored by Eg &G Wallac. 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 1997-11-20.
- Submission: K973276
- Applicant / Sponsor: Eg &G Wallac
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1690
- Decision date: 1997-11-20
Classification & Regulation
This clearance is catalogued under FDA product code JLW and 21 CFR 862.1690, within the Clinical Chemistry review panel as a Class II device.