IVD CAPSULE PSP; abioSCOPE— 510(k) K240041

Substantially Equivalent

Abionic SA

FDA 510(k) clearance K240041 for IVD CAPSULE PSP; abioSCOPE, Substantially Equivalent on 2024-09-25. Applicant: Abionic SA.

Clearance details

Applicant: Abionic SA
Product code: Code SCX
Advisory panel: Microbiology
Date received: 2024-01-05
Decision date: 2024-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Epalinges, CH

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