# K990317: Abbot Liquid Urine Chemistry Control, Model 1E96-01/1E97-01

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Mar 18, 1999 after 48 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Liquid Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the anlaytes listed in the value sheet.

Source page: https://510kreport.com/device/K990317
Methodology: https://510kreport.com/methodology