510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081104Substantially Equivalent

Aeskulisa Ana Hep-2, Ref 30-7115Us

Aesku Diagnostics, Wendelsheim, Rheinland, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K081104 is the FDA 510(k) clearance record for AESKULISA ANA HEP-2, REF 30-7115US, a class II device, cleared for Aesku Diagnostics on under FDA product code LKJ (Antinuclear Antibody, Antigen, Control). FDA records list 9 510(k) clearances for Aesku Diagnostics, from to . As of , FDA records show no recalls naming K081104.

Clearance record

Decision date
Received
(14 days to decision)
Product code
LKJ Antinuclear Antibody, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Aesku Diagnostics Mikroforum Ring 2, Wendelsheim, Rheinland, DE
510(k) summary
Statement
Third party review
Yes

Clearances, product code LKJ

Trailing 12 months

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

FDA records show no clearances under product code LKJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKJ, 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