# K021150: Coulter Cellprep

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 11, 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 COULTER@CellPrep is an automated system that processes human blood for preparation of leukocyte suspensions for quantitative immunofluorescence analysis by optical flow cytometers. The use of data generated by this instrument depends on the regulatory status of the reagents you use. If the reagent is labeled by the manufacturer “For Research Use Onty. Not for use in diagnostic procedures,” federal law prohibits the use of the data for diagnosis. This product is intended “For In Vitro Diagnostic Use” when using the “IVDImmunophenotype”protocol and processing whole blood samples with COULTER reagents and antibodies labeled for In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K021150
Methodology: https://510kreport.com/methodology