Name: Predicase
Price: 199 USD

K-number	DEN230034
Device name	X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
Applicant	Scopio Labs , Ltd.
Product code	SAL
Device class	Class II
Decision date	Mar 22, 2024
Decision	Not Substantially Equivalent
Regulation	864.5261

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Source

View the full FDA submission: accessdata.fda.gov

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X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application

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