ARTSMedia In Vitro Culture Medium (AM-IVC Medium)— 510(k) K220715

Name: FDA 510(k) clearance K220715
Creator: U.S. Food and Drug Administration
Published: 2023-02-10

Substantially Equivalent

Artsmedia Denmark Aps

FDA 510(k) clearance K220715 for ARTSMedia In Vitro Culture Medium (AM-IVC Medium), Substantially Equivalent on 2023-02-10. Applicant: Artsmedia Denmark Aps. Device class: 2.

Clearance details

Applicant: Artsmedia Denmark Aps
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2022-03-11
Decision date: 2023-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virum, DK

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.