Device, Automated Cell Locating, Bone Marrow

SAL · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5261

Classification

FDA Product Code: SAL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.5261
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown