510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220090Unknown

EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)

Stemcell Technologies Canada, Inc., Vancouver, CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220090 is the FDA 510(k) clearance record for EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748), a class II device, cleared for Stemcell Technologies Canada, Inc. on under FDA product code QYO (Hematopoietic Cell Enrichment Kit). FDA's definition for product code QYO reads: "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...". FDA records list one 510(k) clearance for Stemcell Technologies Canada, Inc. As of , FDA records show no recalls naming DEN220090.

Clearance record

Decision date
Received
(329 days to decision)
Product code
QYO Hematopoietic Cell Enrichment Kit
Regulation
21 CFR 866.6120
Device class
Class II
Review panel
Immunology
Applicant
Stemcell Technologies Canada, Inc. 1618 Station St., Vancouver, CA
Third party review
No

Clearances, product code QYO

Trailing 12 months

FDA records hold no clearances under product code QYO in the trailing twelve months.

FDA records show no clearances under product code QYO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260