Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007349751

FEI Number

3007349751

Entity Name

NANOENTEK INC

City/State/Country

Hwaseong Gyeonggi, KR

Establishment Address

851-14, Seohae-ro, Paltan-myeon, Hwaseong Gyeonggi 18531, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NanoEntek, Inc (Owner Number: 10041714)

Owner / Operator Contact Address

220 Bear Hill Road Suite 102, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162378

PMA Number

N/A

All Registered Proprietary Names

FRCOA 020 COVID-19 total Ab Control LQ FREND COVID-19 total Ab with the FREND System ADAM-rWBC HT ADAM-rWBC Kit, ADHK-050 FREND System FREND TSH C-Chip DHC-M01 C-Chip DHC-B02 C-Chip DHC-F01 C-Chip DHC-N01 C-Chip DHC-N04 C-Chip DHC-N0420 C-Chip DHC-F0420 C-Chip DHC-B01 C-Chip DHC-B0420 C-Chip DHC-F04 C-Chip DHC-B04 ADAMII CD34 System FRBR 015 FREND Blocking Reagent FREND Testosterone FREND AP FREND System FREND AP FRENDTM PSA Plus FRENDTM System r-Control RBC and PLT ADAM-rWBC2 (automatic white cell counter) AD1K-050 (ADAM-rWBC disposable kit) ADAMII CD34 System ADAMII-CD34 Kit ADAMII FREND Free T4 Linearity Kit FREND Testosterone Linearity Kit FREND PSA Plus Linearity Kit FREND Vitamin D Linearity Kit FREND TSH Linearity Kit ADAM-rWBC2 (automatic white cell counter) AD1K-050 (ADAM-rWBC disposable kit) F10 FREND System FREND 2 FREND PSA Plus FREND System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-30
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-02-05
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2014-03-16
GHO	Hemocytometer	Hematology	Class 1	864.6160	2018-09-10
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2024-06-26
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-03-16
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2016-10-31
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2018-05-29
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2013-06-10
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2013-06-10
MZG	Test, Residual, Wbc In Leukoreduced Blood	Hematology	Class 2	864.8625	2021-11-08
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-06-11
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-10-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-09-10
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-08-22
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2025-12-15
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2017-05-25

Official Correspondent

No official correspondent registered.

US Agent Details

Jacob Jung Business: NanoEntek America, Inc. Email: jacob@nanoentek.com Phone: (781) 4722558

Related Public Records

Same Entity

NanoEntek, Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007113174	NANOENTEK AMERICA, INC	North Waltham, MA, US
3009092698	NANOENTEK INC	Seoul, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007349751. Last updated year: 2026. Please use registration number 3007349751 when referencing this establishment in official correspondence.