CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER— 510(k) K033840

Clearance details

Applicant

CellaVision AB

Product code

Code JOY

Device class

Class 2

Regulation

21 CFR 864.5260

Advisory panel

Hematology

Date received

2003-12-10

Decision date

2004-02-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis,, MN, US

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• Z-2184-2018 — CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cellsClass II·Ongoing·Cellavision AB·20171204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033840.