# DCK: C-Reactive Protein, Antigen, Antiserum, And Control

- Device class: 2; regulation: 21 CFR 866.5270; FDA's rule: 510(k) required
- FDA decisions: 126
- 510(k) review time 2021–2025: median 588 days (middle half 428–747)
- Recalls: 12 (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: 3
- 2011: 1
- 2012: 1
- 2015: 2
- 2016: 1
- 2017: 1
- 2019: 2
- 2020: 1
- 2022: 1
- 2025: 1

## Most-cited predicates
- K991385: Dade Behring N High Sensitivity CRP Assay (1999), cited by 8
- K962373: N/T Rheumatology Control SL/1 and SL/2 (1996), cited by 6
- K981638: Immage Immunochemistry System C-Reactive Protein (CRP) Reagent (1998), cited by 3
- K962523: N Latex CRP Mono Reagent (1996), cited by 3
- K023828: K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP Multi-Calibrator E, K-Assay CRP Multi-Calibr (2003), cited by 3
- K142993: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument (2016), cited by 2
- K953197: Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP) (1995), cited by 2
- K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set (2011), cited by 2
- K944288: Hemagen C-Reactive Protein Kit (Eia Method) (1994), cited by 2
- K992311: K-Assay CRP (1), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-Calibratorc (1999), cited by 1

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