510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153117Substantially Equivalent

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

Aesku Systems GmbH&Co.Kg, Wendelsheim, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K153117 is the FDA 510(k) clearance record for AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM, a class II device, cleared for Aesku Systems GmbH&Co.Kg on under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control). FDA records list one 510(k) clearance for Aesku Systems GmbH&Co.Kg. As of , FDA records show no recalls naming K153117.

Clearance record

Decision date
Received
(274 days to decision)
Product code
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Aesku Systems GmbH&Co.Kg Mikroforum Ring 3, Wendelsheim, DE
510(k) summary
Statement
Third party review
No

Clearances, product code DHN

Trailing 12 months

FDA records hold no clearances under product code DHN in the trailing twelve months.

FDA records show no clearances under product code DHN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DHN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260