# K141374: Bicarbonate Calibrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter Ireland, Inc.
- Decided: Jun 30, 2014 after 34 days
- Product code: JIT (Calibrator, Secondary)
- 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
Longest line of descent: 1 generation back to K043460 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043460: Olympus Lyophilized Chemistry Calibrators DR0070 and DR0071, Olympus America, Inc. (2005) Summary page 1.

## Indications for use
The Bicarbonate Calibrator is an aqueous preparation of sodium carbonate intended to be used with the Bicarbonate reagent OSR6x37 for the calibration of bicarbonate on Beckman Coulter AU analyser. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K141374
Methodology: https://510kreport.com/methodology