# K033910: Olympus Urine Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Jan 30, 2004 after 44 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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
Olympus T M Urine Calibrator is intended for use in the calibration of quantitative chemistry assays including Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Urea Nitrogen, Uric Acid, and Urinary Total Protein on the OlympusTM series of chemistry analyzers.

Source page: https://510kreport.com/device/K033910
Methodology: https://510kreport.com/methodology