CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)— 510(k) K252672
Substantially EquivalentCasebioscience, 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.. Device class: 2.
Summary
Casebioscience lists two products, CaseBio Culture w/HSA (CMH5) and CaseBio Handling w/HSA (WHH5), under product code MQL, reproductive media. The record doesn't describe either one beyond its name and that code name.
Class II, 21 CFR 884.6180. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Casebioscience filed from Guelph, Canada. The substantially equivalent decision came 179 calendar days after receipt (August 25, 2025 to February 20, 2026).
Clearance details
- Applicant
- Casebioscience, Inc.
- Product code
- Product code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guelph, CA
Recent devices under product code MQL
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