Buhlmann fCAL turbo and CALEX Cap— 510(k) K191718

Name: FDA 510(k) clearance K191718
Creator: U.S. Food and Drug Administration
Published: 2019-09-24

Substantially Equivalent

Buhlmann Laboratories AG

FDA 510(k) clearance K191718 for Buhlmann fCAL turbo and CALEX Cap, Substantially Equivalent on 2019-09-24. Applicant: Buhlmann Laboratories AG. Device class: 2.

Clearance details

Applicant: Buhlmann Laboratories AG
Product code: Code NXO
Device class: Class 2
Regulation: 21 CFR 866.5180
Advisory panel: Immunology
Date received: 2019-06-26
Decision date: 2019-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schönenbuch, CH

Download summary PDF View on FDA.gov ↗

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