510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020496Substantially Equivalent

Hpc (Hematopoietic Progenitor Cell) Parameter on the Imi Channel of the Sysmex Se-9500 and Xe-2100, Automated Hematology

Sysmex Corporation of America, Long Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020496 is the FDA 510(k) clearance record for HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY, a class II device, cleared for Sysmex Corporation of America on under FDA product code GKZ (Counter, Differential Cell). FDA records list 3 510(k) clearances for Sysmex Corporation of America, from to . As of , FDA records show no recalls naming K020496.

Clearance record

Decision date
Received
(57 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Sysmex Corporation of America 6699 Wildlife Way, Long Grove IL
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