# CHH: Enzymatic Esterase--Oxidase, Cholesterol

- Device class: 1; regulation: 21 CFR 862.1175; FDA's rule: 510(k) exempt
- FDA decisions: 230
- 510(k) review time 2021–2025: median 365 days (middle half 315–467)
- Recalls: 13 (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)
- 2013: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 2
- 2019: 1
- 2022: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K861700: Dimension (TM) Clinical Chemistry System (1986), cited by 6
- K981493: MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220 (1998), cited by 4
- K023558: PTS Panels Lipid Panel Test Strips (2002), cited by 4
- K031824: Cobas Integra Cholesterol Gen. 2 (2003), cited by 4
- K990688: MTM Bioscanner C Test Strips (1999), cited by 3
- K934046: Beckman Cholesterol Reagent (1993), cited by 3
- K905405: Chemtrak Accumeter Cholesterol Test (1991), cited by 3
- K950164: Piccolo (TM) Primary Health Panel Reagent Rotor (1995), cited by 2
- K013173: Bioscanner Plus; Lipid Panel Test Strips (2001), cited by 2
- K962890: Cholesterol-Incorporating  Dynamic Stab Tech (DST) (1996), cited by 2

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