# K950481: Neonatal Chemistry System, Galactose Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Isolab, Inc.
- Decided: Feb 1, 1996 after 363 days
- Product code: JIA (Enzymatic Methods, Galactose)
- Device class: 1
- Regulation: 21 CFR 862.1310
- Recalls of this device: 5 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 9, 2004 · Not classified · Z-0515-04: The device is not stable throughout its labeled expiration date.
- Jan 9, 2004 · Not classified · Z-0514-04: The device is not stable throughout its labeled expiration date.
- May 30, 2003 · Not classified · Z-0971-03: The device is not stable throughout its labeled expiration date.
- May 30, 2003 · Not classified · Z-0969-03: The device is not stable throughout its labeled expiration date.
- May 30, 2003 · Not classified · Z-0970-03: The device is not stable throughout its labeled expiration date.

Source page: https://510kreport.com/device/K950481
Methodology: https://510kreport.com/methodology