# K013178: DC-Uibc-CO2-Cal, Model SE-153

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Dec 18, 2001 after 85 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. The FDA summary names its predicate without a number.
- (no number) DC-UIBC-CAL, Cat. No. SE-090: named in the summary without a submission number

## Indications for use
Clinical Chemistry assays may require a point of reference to determine the values of unknown samples. DC-UIBC-CO,-CAL may be used for this purpose in UIBC and CO, assays. Fo. «N VITRO diagnostic use.

Source page: https://510kreport.com/device/K013178
Methodology: https://510kreport.com/methodology