# K042587: Retic-Chex for Cell-Dyn

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Oct 19, 2004 after 27 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K000115 (2000). 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)
- K000115: Retic Chex Linearity, Streck Laboratories, Inc. (2000) Summary page 1.

## Indications for use
Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated and manual methods of reticulocyte counting.

Source page: https://510kreport.com/device/K042587
Methodology: https://510kreport.com/methodology