# K043460: Olympus Lyophilized Chemistry Calibrators DR0070 and DR0071

- Pathway: 510(k) (Abbreviated)
- Applicant: Olympus America, Inc.
- Decided: Jan 31, 2005 after 47 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K141374: Bicarbonate Calibrator (2014), 0 descendants of its own

## Recalls of this device
- Aug 24, 2017 · Class II · Z-0605-2018: Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination.

## Indications for use
The Olympus Lyophilized Chemistry Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.

Source page: https://510kreport.com/device/K043460
Methodology: https://510kreport.com/methodology