# K111204: Cell-Dyn 22 Plus Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Dec 22, 2011 after 237 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
Longest line of descent: 1 generation back to K840261 (1984). 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)
- K840261: Cal-Chex, a Hematology Calibrator, Streck Laboratories, Inc. (1984) Summary page 1.

## Indications for use
CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (109 /L), RBC (1012/L), HOB (g/dL), MCV (fL), PLT (10 1)

Source page: https://510kreport.com/device/K111204
Methodology: https://510kreport.com/methodology