Product code SAL

Device name

Device, Automated Cell Locating, Bone Marrow

Medical specialty

Hematology

Device class

2

Regulation number

864.5261

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type.

Source

FDA openFDA device classification dataset