510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K122821Substantially Equivalent

Celltracks Autoprep System

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

K122821 is the FDA 510(k) clearance record for CELLTRACKS AUTOPREP SYSTEM, a class II device, cleared for Veridex, LLC on under FDA product code NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration). FDA's definition for product code NQI reads: "In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival". FDA records list 12 510(k) clearances for Veridex, LLC, from to . As of , FDA records show 2 recalls naming K122821.

Clearance record

Decision date
Received
(90 days to decision)
Product code
NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Regulation
21 CFR 866.6020
Device class
Class II
Review panel
Immunology
Applicant
Veridex, LLC 1001 U.S. Hwy. 202 N., Raritan NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQI

Trailing 12 months

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

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