# K832713: Iri Spec Urinalysis Control

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Remote Imaging Systems
- Decided: Dec 22, 1983 after 132 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 18, 2012 · Class II · Z-1328-2013: The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not p

Source page: https://510kreport.com/device/K832713
Methodology: https://510kreport.com/methodology