510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K964375Substantially Equivalent

Sysmex Se/ram-1

Sysmex Corporation, Long Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964375 is the FDA 510(k) clearance record for SYSMEX SE/RAM-1, a class II device, cleared for Sysmex Corp. on under FDA product code GKL (Counter, Cell, Automated (Particle Counter)). FDA records list 18 510(k) clearances for Sysmex Corp., from to . As of , FDA records show no recalls naming K964375.

Clearance record

Decision date
Received
(132 days to decision)
Product code
GKL Counter, Cell, Automated (Particle Counter)
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Sysmex Corp. Gilmer Rd., Long Grove IL
510(k) summary
Summary
Third party review
No

Clearances, product code GKL

Trailing 12 months

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

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