Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009034535

FEI Number

3009034535

Entity Name

CELLSOLUTIONS LLC

City/State/Country

Greensboro, NC, US

Establishment Address

1100 Revolution Mill Dr, Greensboro, NC 27405, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CellSolutions LLC (Owner Number: 10045470)

Owner / Operator Contact Address

1100 Revolution Mill Drive, Greensboro, NC 27405, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BTA C-101A General Cytology Preservative CS30 F50 CellSolutions Slides BestCyte Image Display and Training System Cervex-Brush BestPrep General Cytology Preservative

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2024-09-05
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2013-11-27
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2015-04-27
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2013-11-27
OKY	Cytology Kit	Obstetrics/Gynecology	Class 2	884.4530	2013-11-20
NVV	Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System	Clinical Chemistry	Class 1	862.2100	2024-09-05
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2017-01-23
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2013-11-27

Official Correspondent

Joel Dry

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CellSolutions LLC

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
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14
K963801	Young OU Brush Co.	PAP BRUSH	1997-04-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Similar Registrations

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1221855	Hologic, Inc.	LONDONDERRY, NH, US
9710094	YD DIAGNOSTICS	Yongin-si Gyeonggi, KR
3006330030	Hologic, Inc.	Marlborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009034535. Last updated year: 2026. Please use registration number 3009034535 when referencing this establishment in official correspondence.