Data / Medical devices / South Korea / Nanoentek Inc
Nanoentek Inc: FDA-registered device maker in Seoul, South Korea, 6 510(k) clearances
Nanoentek Inc is registered with the FDA (registration 3009092698) in Seoul, 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
- 3009092698
- Address
- 12F, 5, Digital-ro 26-gil Guro-gu, Seoul, South Korea, 08389
- Owner or operator
- NanoEntek, Inc (10041714)
- Roles
- Complaint file establishment, 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
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 |
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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.