510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902391Substantially Equivalent

Cell-Dyn 3000 Control

Unipath, Ltd., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902391 is the FDA 510(k) clearance record for CELL-DYN 3000 CONTROL, a class II device, cleared for Unipath , Ltd. on under FDA product code JCN (Control, Cell Counter, Normal And Abnormal). FDA records list 73 510(k) clearances for Unipath , Ltd., from to . As of , FDA records show no recalls naming K902391.

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
Unipath , Ltd. 850 Maude Ave., Mountain View CA
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