510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963263Substantially Equivalent

Tetraone System for Epics Xl Flow Cytometry Systems and Cyto-Stat Tertrachrome Cd45-Fitc/cd4-Rdi/cd8-Ecd/cd3-Pc5

Coulter Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963263 is the FDA 510(k) clearance record for TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5, a class II device, cleared for Coulter Corp. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 51 510(k) clearances for Coulter Corp., from to . As of , FDA records show one recall naming K963263.

Clearance record

Decision date
Received
(155 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Coulter Corp. 11800 SW 147th Ave., Miami FL
510(k) summary
Summary
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