AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10— 510(k) K172348

Name: FDA 510(k) clearance K172348
Creator: U.S. Food and Drug Administration
Published: 2018-02-16

Substantially Equivalent

Aesku.Diagnostics GmbH & Co. KG

FDA 510(k) clearance K172348 for AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10, Substantially Equivalent on 2018-02-16. Applicant: Aesku.Diagnostics GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Aesku.Diagnostics GmbH & Co. KG
Product code: Code LSW
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2017-08-03
Decision date: 2018-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wendeslheim, DE

Download summary PDF View on FDA.gov ↗

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