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510(k) K153117

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM by Aesku Systems GmbH&Co.Kg — Product Code DHN

K153117 is an FDA 510(k) premarket notification submitted by Aesku Systems GmbH&Co.Kg for the device "AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 2016. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2016
Date Received
October 28, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • K172745 — ImmuGlo HEp-2 Elite IFA (June 5, 2018)
  • K160265 — Image Navigator by Immuno Concepts (June 17, 2016)
  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)
  • K150155 — NOVA Lite DAPI ANA Kit (April 8, 2015)
  • K131791 — IFA 40: HEP-20-10 (February 26, 2014)
  • K120889 — AESKUSLIDES ANA HEP-2 (October 15, 2012)
  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)
  • K024220 — LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 (January 17, 2003)

FDA data resources