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Casebioscience, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K252672
CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
February 20, 2026
K242107
CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF
March 21, 2025