FDA 510(k)

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

K-Number: K252672 · 2026-02-20

Decision Date2026-02-20

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) is a medical device manufactured by Casebioscience, Inc.. It received FDA 510(k) clearance on 2026-02-20 under approval number K252672. 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 CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)?

CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) is a medical device that received FDA 510(k) clearance on 2026-02-20. It is manufactured by Casebioscience, Inc.. The 510(k) number is K252672.

When was CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) approved by the FDA?

CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) received FDA 510(k) clearance on 2026-02-20, under approval number K252672.

What company makes CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)?

CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) is manufactured by Casebioscience, Inc..

What is the FDA product code for CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)?

The FDA product code for CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) is MQL.

Other Devices by Casebioscience, Inc.

K242107CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

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Official Source

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