# JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

- Device class: 1; regulation: 21 CFR 862.2300; FDA's rule: 510(k) exempt
- FDA decisions: 258
- 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)
- 1989: 20
- 1990: 16
- 1991: 17
- 1992: 14
- 1993: 6
- 1994: 4
- 1995: 12
- 1996: 3
- 1998: 3
- 2001: 1

## Most-cited predicates
- K932467: Ilab 900/1800 Clinical Chemistry System (1993), cited by 4
- K013371: Ubit-IR300 Infrared Spectrometry System (2001), cited by 3
- K943595: Serum/Urine Appli Ilab (TM) Clinical Chemistry System (1994), cited by 3
- K931907: Anthos HT Readers, Including the Anthos HT II&Iii (1993), cited by 2
- K894270: Denley Anthos 2001 Reader (1989), cited by 2
- K921180: Cobas Core Immunochemistry System (1992), cited by 1
- K853453: Bio Automed Sys Chemistry Analyzer Auto-Loader (1985), cited by 1
- K953710: ELX808 Automated Microplate Readers (1995), cited by 1
- K950104: ELX800 and EL800 Automated Microplate Readers (1995), cited by 1
- K842085: Automated Eia Microplate Reader EL310 (1984), cited by 1

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