510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822823Substantially Equivalent

Hematology Computer-Interface, Viscount

Eko Scann AB, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822823 is the FDA 510(k) clearance record for HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT, a class II device, cleared for Eko Scann AB on under FDA product code LKM (Counter, Urine Particle). FDA records list 2 510(k) clearances for Eko Scann AB, from to . As of , FDA records show no recalls naming K822823.

Clearance record

Decision date
Received
(27 days to decision)
Product code
LKM Counter, Urine Particle
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Eko Scann AB 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LKM

Trailing 12 months

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

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