QYO · Class II · 21 CFR 866.6120

FDA Product Code QYO: Hematopoietic Cell Enrichment Kit

A Hematopoietic Cell Enrichment Kit Is An In Vitro Diagnostic Device Intended For The Selection And Enrichment Of Specific Hematopoietic Cells From Human Whole Blood And/or Bone Marrow Collected From Patients With Hematological Malignancies Using Immunomagnetic Bead-based Selection. It Is Intended For Use With Diagnostic Assays As Part Of The Pre-analytical Workflow.

Leading manufacturers include Stemcell Technologies Canada, Inc..

1
Total
0
Cleared
329d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Hematopoietic Cell Enrichment Kit Devices (Product Code QYO)

1 devices
1–1 of 1
Not Cleared Nov 06, 2023
EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
DEN220090
Stemcell Technologies Canada, Inc.
Pathology · 329d

About Product Code QYO - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QYO since 2023, with 0 receiving FDA clearance (average review time: 329 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QYO devices are reviewed by the Pathology panel. Browse all Pathology devices →