# CJY: Azo Dye, Calcium

- Device class: 2; regulation: 21 CFR 862.1145; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 42 days (middle half 42–42)
- Recalls: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 2
- 2007: 2
- 2008: 2
- 2009: 1
- 2012: 1
- 2013: 1
- 2015: 1
- 2018: 1
- 2019: 1
- 2025: 1

## Most-cited predicates
- K061575: Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117 (2006), cited by 2
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), cited by 2
- K062855: Calcium (2006), cited by 1
- K883453: Roche Reagent for Calcium (1988), cited by 1
- K981578: CA (1998), cited by 1
- K941764: Hichem Calcium Reagent for the Synchron CX3 Prod. NO. 88808 (1994), cited by 1
- K961226: Ektachem Clinical Chemistry Calcium (CA) Slide (1996), cited by 1
- K072440: Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208) (2007), cited by 1
- K083386: Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915 (70 ML Fill) (2009), cited by 1
- K072443: Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay (2007), cited by 1

Source page: https://510kreport.com/product-code/CJY
Data by year (CSV): https://510kreport.com/product-code/CJY.csv