Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Nanoentek and its 1 subsidiaries with 6 510(k) clearances. The most recent is a 510(k) clearance dated May 17, 2017: FREND PSA PLUS (reagent cartridge).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Nanoentek and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 17, 2017 | FREND PSA PLUS (reagent cartridge)K162378 · LTJ | 510(k) clearances |
| Jan 12, 2017 | FREND Vitamin D Test SystemK162754 · MRG | 510(k) clearances |
| Oct 14, 2016 | FREND Testosterone Test SystemK153577 · CDZ | 510(k) clearances |
| Feb 17, 2016 | FREND™ Free T4 Test SystemK152422 · CEC | 510(k) clearances |
| Mar 14, 2014 | FREND TSH (REAGENT CARTRIDGE)K131928 · JLW | 510(k) clearances |
| May 29, 2013 | FREND PSA PLUS (REAGENT CARTRIDGE)K124056 · LTJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
