CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)— 510(k) K242107

Name: FDA 510(k) clearance K242107
Creator: U.S. Food and Drug Administration
Published: 2025-03-21

Substantially Equivalent

Casebioscience, Inc.

FDA 510(k) clearance K242107 for CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF), Substantially Equivalent on 2025-03-21. Applicant: Casebioscience, Inc.. Device class: 2.

Clearance details

Applicant: Casebioscience, Inc.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2024-07-18
Decision date: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guelph, CA

Download summary PDF View on FDA.gov ↗

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