510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902389Substantially Equivalent

Tri-Count 16

Hematronix, Inc., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902389 is the FDA 510(k) clearance record for TRI-COUNT 16, a class II device, cleared for Hematronix, Inc. on under FDA product code JCN (Control, Cell Counter, Normal And Abnormal). FDA records list 9 510(k) clearances for Hematronix, Inc., from to . As of , FDA records show no recalls naming K902389.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JCN Control, Cell Counter, Normal And Abnormal
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Hematronix, Inc. 1505 Capital Ave., Plano TX
Third party review
No

Clearances, product code JCN

Trailing 12 months

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

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