510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021150Substantially Equivalent

Coulter Cellprep

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

K021150 is the FDA 510(k) clearance record for COULTER CELLPREP, a class I device, cleared for Beckman Coulter, Inc. on under FDA product code GKH (Apparatus, Automated Blood Cell Diluting). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K021150.

Clearance record

Decision date
Received
(62 days to decision)
Product code
GKH Apparatus, Automated Blood Cell Diluting
Regulation
21 CFR 864.5240
Device class
Class I
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 GKH

Trailing 12 months

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

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