510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060110Substantially Equivalent

Celltracks Analyzer II

Immunicon Corp., Huntingdon Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060110 is the FDA 510(k) clearance record for CELLTRACKS ANALYZER II, a class II device, cleared for Immunicon Corp. 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 6 510(k) clearances for Immunicon Corp., from to . As of , FDA records show one recall naming K060110.

Clearance record

Decision date
Received
(58 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
Immunicon Corp. 3401 Masons Mill Rd., Huntingdon Valley PA
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