# DEN990008: Wallac Neonatal Biotinidase Test Kit, Models NB-1000; NB-4000

- Pathway: De Novo (Post-NSE)
- Applicant: Wallac, Inc.
- Decided: Feb 15, 2000 after 57 days
- Product code: NAK (System, Test, Biotinidase)
- Device class: 2
- Regulation: 21 CFR 862.1118
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

Source page: https://510kreport.com/device/DEN990008
Methodology: https://510kreport.com/methodology