Clearance Summary
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 received FDA 510(k) clearance under submission number DEN990008, sponsored by Wallac, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2000-02-15.
- Submission: DEN990008
- Applicant / Sponsor: Wallac, Inc.
- Clearance pathway: Post-NSE
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1118
- Decision date: 2000-02-15
Classification & Regulation
This clearance is catalogued under FDA product code NAK and 21 CFR 862.1118, within the Clinical Chemistry review panel as a Class II device.