Cleared Traditional

AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10

K172348 · Aesku.Diagnostics GmbH & Co. KG · Immunology

Feb 2018

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K172348 is an FDA 510(k) clearance for the AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10, a Anti-dna Antibody, Antigen And Control (Class II — Special Controls, product code LSW), submitted by Aesku.Diagnostics GmbH & Co. KG (Wendeslheim, DE). The FDA issued a Cleared decision on February 16, 2018, 197 days after receiving the submission on August 3, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K172348 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2017
Decision Date	February 16, 2018
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF