# K022512: Cellprep Sample Preparation System, Model 9518

- Pathway: 510(k) (Traditional)
- Applicant: Immunicon Corp.
- Decided: Sep 30, 2002 after 62 days
- Product code: GKH (Apparatus, Automated Blood Cell Diluting)
- Device class: 1
- Regulation: 21 CFR 864.5240
- 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) Coulter Multi-Q-Prep: named in the summary without a submission number

## Indications for use
The Immunicon CellPrepTM Sample Preparation System is a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracksTM Analyzer, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K022512
Methodology: https://510kreport.com/methodology