# K033643: CO2 Calibrator/Diluent

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, Diagnostics Division
- Decided: Jan 8, 2004 after 49 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 K990460 (1999). 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)
- K990460: Calibrator for Automated Systems (C.F.a.S.), Roche Diagnostics Corp. (1999) Summary page 1.

## Indications for use
The CO 2 Calibrator/Diluent is intended for in vitro diagnostic use to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product.

Source page: https://510kreport.com/device/K033643
Methodology: https://510kreport.com/methodology