CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001— 510(k) K103502

Clearance details

Applicant

Veridex, LLC

Product code

Code NQI

Device class

Class 2

Regulation

21 CFR 866.6020

Advisory panel

Immunology

Date received

2010-11-29

Decision date

2010-12-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Raritan, NJ, US

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• Z-1345-2022 — CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001Class II·Ongoing·Menarini Silicon Biosystems·20220520
• Z-1530-2018 — CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.Class II·Terminated·Menarini Silicon Biosystems·20180404
• Z-2406-2015 — Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.Class II·Terminated·Veridex, LLC·20150515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103502.