# K883453: Roche Reagent for Calcium

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Oct 25, 1988 after 74 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K060205: General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer (2006), 1 descendant of its own
- K100263: Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K883453
Methodology: https://510kreport.com/methodology