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.. Device class: 2.

Clearance details

Applicant
Casebioscience, Inc.
Product code
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
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