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
K022161Substantially Equivalent

Modification to Coulter Lh 750 Hematology Analyzer, Model 6605632

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

K022161 is the FDA 510(k) clearance record for MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show 2 recalls naming K022161.

Clearance record

Decision date
Received
(26 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
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 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