# K020469: Cal-Chex CD Plus

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Apr 4, 2002 after 51 days
- Product code: KRX (Calibrator For Cell Indices)
- Device class: 2
- Regulation: 21 CFR 864.8150
- 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) Cal-Chex: named in the summary without a submission number

## Indications for use
Cal-Chex CD Plus is used to calibrate the WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) parameters on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.

Source page: https://510kreport.com/device/K020469
Methodology: https://510kreport.com/methodology