# K973276: Autodelfia Neonatal HTSH L Kit (B077-112)

- Pathway: 510(k) (Traditional)
- Applicant: Eg &G Wallac
- Decided: Nov 20, 1997 after 79 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- 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. The FDA summary names its predicate without a number.
- (no number) AutoDELFIA™ Neonatal hTSH Kit: named in the summary without a submission number

## Indications for use
This kit is intended for the quantitative determination of thyrotropin in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism, using the 1235 AutoDELFIA™ automatic immunoassay system.

Source page: https://510kreport.com/device/K973276
Methodology: https://510kreport.com/methodology