BUHLMANN fCAL ELISA— 510(k) K181012

Substantially Equivalent

Buhlmann Laboratories AG

FDA 510(k) clearance K181012 for BUHLMANN fCAL ELISA, Substantially Equivalent on 2018-06-04. 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: 2018-04-17
Decision date: 2018-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schonenbuch, CH

Download summary PDF View on FDA.gov ↗

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