Devices · CELLAVISION AB

CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION

CELLAVISION AB is listed for CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (K102778). The FDA list gives September 16, 2011 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JOY. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K102778

Official FDA database record

Date of final decision

September 16, 2011

Company on the FDA list

CELLAVISION AB

Lead panel

Hematology

Primary product code

JOY

openFDA device name for the code

Device, Automated Cell-Locating

Device class

2

Regulation number

864.5260

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary