510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K100489Substantially Equivalent

Dxh 300 Coulter Cellular Analysis System, Dxh 300C Coulter Cellular Analyssi System Model: 71772, 71771

Beckman Coulter Cellular, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100489 is the FDA 510(k) clearance record for DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771, a class II device, cleared for Beckman Coulter Cellular on under FDA product code GKZ (Counter, Differential Cell). FDA records list one 510(k) clearance for Beckman Coulter Cellular. As of , FDA records show no recalls naming K100489.

Clearance record

Decision date
Received
(249 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Beckman Coulter Cellular 11800 SW 147 Ave., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260