# JJF: Analyzer, Chemistry, Micro, For Clinical Use

- Device class: 1; regulation: 21 CFR 862.2170; FDA's rule: 510(k) exempt
- FDA decisions: 57
- Recalls: 11 (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)
- 1994: 1
- 1995: 1
- 1996: 1
- 1997: 5
- 1998: 2
- 1999: 1
- 2002: 2
- 2003: 1
- 2004: 1
- 2006: 1

## Most-cited predicates
- K942676: Synchron CX3 Delta (1994), cited by 5
- K864236: Synchron CX3 (1986), cited by 4
- K851172: Cobas Mira (1985), cited by 3
- K033734: Lightcycler Instrument Version 1.2 (2003), cited by 3
- K012966: Roche Cobas Taqman Analyzer (2002), cited by 2
- K971491: Synermed IR 200 Chemistry Analyzer (1997), cited by 2
- K973177: Mago Automated Eia Processor (1997), cited by 1
- K013654: Precision Systems Analette Chemistry Analyzer (2002), cited by 1
- K964506: Roche Cobas Amplicor Analyzer (1997), cited by 1
- K973628: Vitalab Flexor/Vitalab Selectra 2/Vitalab Viva (1998), cited by 1

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