# K080595: Cellavision DM96 with the Body Fluid Application

- Pathway: 510(k) (Traditional)
- Applicant: CellaVision AB
- Decided: Dec 5, 2008 after 277 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925670 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033840: Cellavision DM96 Automatic Hematology Analyzer, CellaVision AB (2004) Summary page 1.
- (no number) Romanowsky stain manual light microscopic process for cell classification: named in the summary without a submission number

## Most influential descendants
- K102778: Cellavision DM1200 with the Body Fluid Appliction (2011), 0 descendants of its own

## Indications for use
DM96 is an automated cell-locating device. The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. The operator identifies and verifies the suggested classification of each cell according to type. DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.

Source page: https://510kreport.com/device/K080595
Methodology: https://510kreport.com/methodology