510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040898Substantially Equivalent

Cellsearch Epithelial Cell Control Kit

Veridex, LLC, Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040898 is the FDA 510(k) clearance record for CELLSEARCH EPITHELIAL CELL CONTROL KIT, a class II device, cleared for Veridex, LLC on under FDA product code NRS (Control Material, Blood Circulating Epithelial Cancer Cell). FDA's definition for product code NRS reads: "The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality...". FDA records list 12 510(k) clearances for Veridex, LLC, from to . As of , FDA records show one recall naming K040898.

Clearance record

Decision date
Received
(83 days to decision)
Product code
NRS Control Material, Blood Circulating Epithelial Cancer Cell
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Veridex, LLC 1001 U.S. Hwy. 202, Raritan NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRS

Trailing 12 months

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

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