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FDA 510(k)

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

K-Number: K242107 · 2025-03-21

ApplicantCasebioscience, Inc.
Decision Date2025-03-21
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) is a medical device manufactured by Casebioscience, Inc.. It received FDA 510(k) clearance on 2025-03-21 under approval number K242107. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)?

CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Casebioscience, Inc.. The 510(k) number is K242107.

When was CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) approved by the FDA?

CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) received FDA 510(k) clearance on 2025-03-21, under approval number K242107.

What company makes CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)?

CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) is manufactured by Casebioscience, Inc..

What is the FDA product code for CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)?

The FDA product code for CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) is MQL.

Other Devices by Casebioscience, Inc.

K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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