510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210127Substantially Equivalent

iQ200 System, iChemVELOCITY Automated Urine Chemistry System

Siemens Healthcare Diagnostics Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210127 is the FDA 510(k) clearance record for iQ200 System, iChemVELOCITY Automated Urine Chemistry System, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code LKM (Counter, Urine Particle). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show 4 recalls naming K210127.

Clearance record

Decision date
Received
(164 days to decision)
Product code
LKM Counter, Urine Particle
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Beckman Coulter, Inc. 11800 SW 147th Ave., Miami FL
510(k) summary
Summary PDF
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