# K943493: Discrete Photometric Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Co.
- Decided: Jan 30, 1995 after 195 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Sep 26, 2011 · Not classified · Z-0103-2012: Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation".

Source page: https://510kreport.com/device/K943493
Methodology: https://510kreport.com/methodology