K-number	K240041
Device name	IVD CAPSULE PSP; abioSCOPE
Applicant	Abionic SA
Product code	SCX
Device class	Class II
Decision date	Sep 25, 2024
Decision	Substantially Equivalent
Regulation	866.3215

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Source

View the full FDA submission: accessdata.fda.gov

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IVD CAPSULE PSP; abioSCOPE

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