BUHLMANN fCAL turbo— 510(k) K190784

Substantially Equivalent

Buhlmann Laboratories AG

FDA 510(k) clearance K190784 for BUHLMANN fCAL turbo, Substantially Equivalent on 2019-06-25. 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: 2019-03-27
Decision date: 2019-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schönenbuch, CH

Download summary PDF View on FDA.gov ↗

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