De Novo DEN040001

Device: CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
Contact: debra j rasmussen
De Novo number: DEN040001
Product code: NQI
Regulation: 866.6020
Classification name: system, immunomagnetic, circulating cancer cell, enumeration
Decision: granted (DENG)
Decision date: 2004-01-21
Date received: 2004-01-02
Classification advisory: Immunology
Review advisory: Pathology
Type: Post-NSE

Current FDA Classification#

Primary DI, Device, Company table
Primary DI	Device	Company	Published
00041520113429	Care One	Ahold U.S.A., Inc.	2021-08-26
10888385000658	CELLTRACKS ANALYZER II	MENARINI SILICON BIOSYSTEMS, INC.	2020-07-10
10888385000665	CELLTRACKS AUTOPREP	MENARINI SILICON BIOSYSTEMS, INC.	2020-07-10
10888385000016	CellSearch	MENARINI SILICON BIOSYSTEMS, INC.	2016-09-22
10888385000054	CELLTRACKS ANALYZER II	MENARINI SILICON BIOSYSTEMS, INC.	2016-09-22
10888385000085	CELLTRACKS ANALYZER II	MENARINI SILICON BIOSYSTEMS, INC.	2016-09-22
10888385000627	CELLTRACKS ANALYZER II	MENARINI SILICON BIOSYSTEMS, INC.	2016-09-22
10888385000061	CELLTRACKS AUTOPREP	MENARINI SILICON BIOSYSTEMS, INC.	2016-09-22
10888385000078	CELLTRACKS AUTOPREP	MENARINI SILICON BIOSYSTEMS, INC.	2016-09-22
10888385000610	CELLTRACKS AUTOPREP	MENARINI SILICON BIOSYSTEMS, INC.	2016-09-22