# K913124: Roche Reagent for Ammonia

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Aug 12, 1991 after 28 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 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
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents (1997), 17 descendants of its own
- K980996: Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) (1998), 9 descendants of its own
- K031879: Cobas Integra Carbon Dioxide Assay (2003), 8 descendants of its own
- K032377: Roche Diagnostics Hitachi Bicarbonate Liquid (2003), 2 descendants of its own
- K183555: GEM Premier ChemSTAT (2019), 1 descendant of its own

Source page: https://510kreport.com/device/K913124
Methodology: https://510kreport.com/methodology