Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004153557

FEI Number

3004153557

Entity Name

Menarini Silicon Biosystems Inc.

City/State/Country

Huntingdon Valley, PA, US

Establishment Address

3401 Masons Mill road, Suite 100, Huntingdon Valley, PA 19006, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Menarini Silicon Biosystems Inc. (Owner Number: 10054393)

Owner / Operator Contact Address

3401 Masons Mill Road, Suite 100, Huntingdon Valley, PA 19006, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103502

PMA Number

N/A

All Registered Proprietary Names

CellSearch Collection Kit CellSearch AutoPrep Samples Prep system CellSearch CTC Enumeration System CellSearch CTC Control Kit CellSearch CTC Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2017-04-06
GKH	Apparatus, Automated Blood Cell Diluting	Hematology	Class 1	864.5240	2017-03-14
NQI	System, Immunomagnetic, Circulating Cancer Cell, Enumeration	Immunology	Class 2	866.6020	2017-04-06
NRS	Control Material, Blood Circulating Epithelial Cancer Cell	Hematology	Class 2	864.8625	2017-04-06
NQI	System, Immunomagnetic, Circulating Cancer Cell, Enumeration	Immunology	Class 2	866.6020	2017-04-06

Official Correspondent

Thomas Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Menarini Silicon Biosystems Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004153557. Last updated year: 2026. Please use registration number 3004153557 when referencing this establishment in official correspondence.