# K950803: Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample

- Pathway: 510(k) (Traditional)
- Applicant: Isolab, Inc.
- Decided: Sep 21, 1995 after 212 days
- Product code: JJT (Enzyme Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K100101: GSP Neonatalgalt Kit, Model 3303-001U (2010), 0 descendants of its own

## Recalls of this device
- Jun 27, 2003 · Not classified · Z-1139-03: The kits are producing lower values than expected, which may result in an increase of false positive test results.
- Jan 8, 2003 · Not classified · Z-0898-03: The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.

Source page: https://510kreport.com/device/K950803
Methodology: https://510kreport.com/methodology