510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232600Substantially Equivalent

DxFLEX Flow Cytometer; ClearLLab 10C Panels

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

K232600 is the FDA 510(k) clearance record for DxFLEX Flow Cytometer; ClearLLab 10C Panels, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code OYE (Flow Cytometric Reagents And Accessories.). FDA's definition for product code OYE reads: "To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level...". FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show one recall naming K232600.

Clearance record

Decision date
Received
(86 days to decision)
Product code
OYE Flow Cytometric Reagents And Accessories.
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Beckman Coulter, Inc. 11800 SW 147 Ave., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYE

Trailing 12 months

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

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