BÜHLMANN fCAL® turbo and CALEX® Cap— 510(k) K232057

Name: FDA 510(k) clearance K232057
Creator: U.S. Food and Drug Administration
Published: 2024-02-06

Substantially Equivalent

Bühlmann Laboratories AG

FDA 510(k) clearance K232057 for BÜHLMANN fCAL® turbo and CALEX® Cap, Substantially Equivalent on 2024-02-06. Applicant: Bühlmann Laboratories AG. Device class: 2.

Clearance details

Applicant: Bühlmann Laboratories AG
Product code: Code NXO
Device class: Class 2
Regulation: 21 CFR 866.5180
Advisory panel: Immunology
Date received: 2023-07-11
Decision date: 2024-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Schönenbuch, CH

Download summary PDF View on FDA.gov ↗

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