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

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..

Clearance details

Applicant
Casebioscience, Inc.
Product code
Code MQL
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guelph, CA
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