# K961432: Radias Galt Test

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Oct 28, 1996 after 196 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K990827: Microplate Neonatal Galt Assay (1999), 3 descendants of its own
- K102643: Spotcheck Neonatal Galt Microplate Reagent Kit (2011), 0 descendants of its own
- K090940: Spotcheck Blood Spot Control, Assayed (2009), 0 descendants of its own
- K993536: Bio-Rad Coda Neonatal Galt Assay (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K961432
Methodology: https://510kreport.com/methodology