CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)— 510(k) K252672

Substantially Equivalent

Casebioscience, Inc.

FDA 510(k) clearance K252672 for CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5), Substantially Equivalent on 2026-02-20. Applicant: Casebioscience, Inc..

Clearance details

Applicant: Casebioscience, Inc.
Product code: Code MQL
Advisory panel: Obstetrics/Gynecology
Date received: 2025-08-25
Decision date: 2026-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guelph, CA

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