510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K081822Substantially Equivalent

Coulter 6C Cell Control, Models 628027 & A59925

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

K081822 is the FDA 510(k) clearance record for COULTER 6C CELL CONTROL, MODELS 628027 & A59925, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K081822.

Clearance record

Decision date
Received
(208 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
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 JPK

Trailing 12 months

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

FDA records show no clearances under product code JPK in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JPK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260