Data / Medical devices / South Korea / Nanoentek Inc

Nanoentek Inc: FDA-registered device maker in Hwaseong Gyeonggi, South Korea, 6 510(k) clearances

Name: Nanoentek Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nanoentek Inc is registered with the FDA (registration 3007349751) in Hwaseong Gyeonggi, South Korea. It lists 17 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 17, 2017. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007349751
Address: 851-14, Seohae-ro, Paltan-myeon, Hwaseong Gyeonggi, South Korea, 18531
Owner or operator: NanoEntek, Inc (10041714)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: August 22, 2012
Registered through: 2027
Brand names listed: AD1K-050 (ADAM-rWBC disposable kit), ADAM-rWBC HT, ADAM-rWBC Kit, ADHK-050, ADAM-rWBC2 (automatic white cell counter), ADAMII, ADAMII CD34 System, ADAMII-CD34 Kit, C-Chip DHC-B01 and more

Devices it lists

Device	Product code	Class	Role	Source
Block, Heating	JRG	1	Manufacturer	accessdata.fda.gov
Counter, Differential Cell	GKZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Fluorometer, For Clinical Use	KHO	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Hemocytometer	GHO	1	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Specification developer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Specification developer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Manufacturer	accessdata.fda.gov
Test, Residual, Wbc In Leukoreduced Blood	MZG	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 17, 2017	K162378	FREND PSA PLUS (reagent cartridge)	LTJ	Substantially Equivalent	Nanoentek USA, Inc.	accessdata.fda.gov
January 12, 2017	K162754	FREND Vitamin D Test System	MRG	Substantially Equivalent	Nanoentek USA, Inc.	accessdata.fda.gov
October 14, 2016	K153577	FREND Testosterone Test System	CDZ	Substantially Equivalent	Nanoentek USA, Inc.	accessdata.fda.gov
February 17, 2016	K152422	FREND Free T4 Test System	CEC	Substantially Equivalent	Nanoentek USA, Inc.	accessdata.fda.gov
March 14, 2014	K131928	FREND TSH (REAGENT CARTRIDGE)	JLW	Substantially Equivalent	Nanoentek USA, Inc.	accessdata.fda.gov
May 29, 2013	K124056	FREND PSA PLUS (REAGENT CARTRIDGE)	LTJ	Substantially Equivalent	Nanoentek, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 17, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.