510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081251Substantially Equivalent

Modification to Aeskulisa Ds DNA G

Aesku Diagnostics, Wendelsheim, Rheinland, DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081251 is the FDA 510(k) clearance record for MODIFICATION TO AESKULISA DS DNA G, a class II device, cleared for Aesku Diagnostics on under FDA product code LSW (Anti-Dna Antibody, Antigen And Control). FDA records list 9 510(k) clearances for Aesku Diagnostics, from to . As of , FDA records show no recalls naming K081251.

Clearance record

Decision date
Received
(11 days to decision)
Product code
LSW Anti-Dna Antibody, Antigen And 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
Summary PDF
Third party review
Yes

Clearances, product code LSW

Trailing 12 months

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

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