Name: Predicase
Price: 199 USD

K-number	K220013
Device name	X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
Applicant	Scopio Labs , Ltd.
Product code	JOY
Device class	Class II
Decision date	May 3, 2022
Decision	Substantially Equivalent
Regulation	864.5260

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Source

View the full FDA submission: accessdata.fda.gov

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X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

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