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510(k) K172348

AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 by Aesku.Diagnostics GmbH & Co. KG — Product Code LSW

K172348 is an FDA 510(k) premarket notification submitted by Aesku.Diagnostics GmbH & Co. KG for the device "AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10". The FDA issued a decision of Substantially Equivalent on February 16, 2018. The device falls under product code LSW (Anti-Dna Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Aesku.Diagnostics GmbH & Co. KG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2018
Date Received
August 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Aesku.Diagnostics GmbH & Co. KG

  • K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (March 23, 2018)

Other clearances for product code LSW

  • K152013 — QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Contro (April 11, 2016)
  • K081251 — MODIFICATION TO AESKULISA DS DNA G (May 13, 2008)
  • K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (December 7, 2007)
  • K060380 — FIDIS DSDNA (May 2, 2006)
  • K041628 — AESKULISA DS DNA G (October 14, 2004)
  • K921658 — ANTI-DSDNA ANTIBODY TEST (March 22, 1993)
  • K872085 — THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS (September 1, 1987)

FDA data resources