Name: Predicase
Price: 199 USD

K-number	DEN220090
Device name	EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)
Applicant	Stemcell Technologies Canada, Inc.
Product code	QYO
Device class	Class II
Decision date	Nov 6, 2023
Decision	Not Substantially Equivalent
Regulation	866.6120

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.

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