Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009092698

FEI Number

3009092698

Entity Name

NANOENTEK INC

City/State/Country

Seoul, KR

Establishment Address

12F, 5, Digital-ro 26-gil, Guro-gu, Seoul 08389, KR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

N/A

PMA Number

N/A

All Registered Proprietary Names

F10 FREND System FREND 2 FREND Free T4 Linearity Kit FREND Testosterone Linearity Kit FREND PSA Plus Linearity Kit FREND Vitamin D Linearity Kit FREND TSH Linearity Kit FREND PSA Plus FREND System ADAMII CD34 System FRBR 015 FREND Blocking Reagent FREND AP ADAM-rWBC2 (automatic white cell counter) AD1K-050 (ADAM-rWBC disposable kit) FREND Vitamin D FREND System FREND AP ADAM-rWBC2 (automatic white cell counter) AD1K-050 (ADAM-rWBC disposable kit) ADAM-rWBC HT ADAM-rWBC Kit, ADHK-050 ADAMII CD34 System ADAMII-CD34 Kit ADAMII FRCOA 020 COVID-19 total Ab Control LQ FREND COVID-19 total Ab with the FREND System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2025-12-15
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-09-10
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2017-05-25
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2024-06-26
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-03-16
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2018-05-29
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-08-22
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2017-01-18
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-06-11
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-02-05
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-10-09
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-30

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
3007349751	NANOENTEK INC	Hwaseong Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
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).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009092698. Last updated year: 2026. Please use registration number 3009092698 when referencing this establishment in official correspondence.