# K102778: Cellavision DM1200 with the Body Fluid Appliction

- Pathway: 510(k) (Traditional)
- Applicant: CellaVision AB
- Decided: Sep 16, 2011 after 357 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: 4 generations back to K925670 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080595: Cellavision DM96 with the Body Fluid Application, CellaVision AB (2008) Summary page 1.

## Indications for use
DM 1200 is an automated system intended for in-vitro diagnostic use. 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. DM1200 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/K102778
Methodology: https://510kreport.com/methodology