# JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

- Device class: 1; regulation: 21 CFR 862.2160; FDA's rule: 510(k) exempt
- FDA decisions: 208
- Recalls: 327 (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)
- 2003: 1
- 2004: 2
- 2005: 4
- 2006: 1
- 2008: 1
- 2011: 2
- 2012: 1
- 2013: 1
- 2014: 3
- 2019: 1

## Most-cited predicates
- K912844: Kodak Ektachem Dtii System (1991), cited by 29
- K931786: Ace Clinical Chemistry  System (1993), cited by 22
- K860021: Dimension (TM) Clinical Chemistry System (1986), cited by 9
- K961274: Olympus AU600 Clinical Chemistry Analyzer (1996), cited by 6
- K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L (1997), cited by 5
- K811194: Hitachi 705 Automatic Blood Chemistry (1981), cited by 5
- K953239: Boehringer Mannheim/Hitachi 917 Analyzer (1995), cited by 5
- K863840: Meth. & Cali. for the Dimension Clini/Chem. System (1986), cited by 5
- K872494: Hitachi 717 Chemistry Analyzer (1987), cited by 5
- K961481: Elecsys 2010 Analyzer (1996), cited by 4

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