NANOENTEK INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007349751 | 3007349751 | NANOENTEK INC | 1 | N | 2026-01-01 | 851-14, Seohae-ro, Paltan-myeon Hwaseong Gyeonggi KR 18531 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 190925 | 1595159786 | K162754 | FREND Vitamin D Test System | MRG | 2017-01-12 |
| 190925 | 1376110387 | K162378 | FREND PSA PLUS (reagent cartridge) | LTJ | 2017-05-17 |
| 190925 | 1441399359 | K153577 | FREND Testosterone Test System | CDZ | 2016-10-14 |
| 190925 | 1063264547 | K152422 | FREND™ Free T4 Test System | CEC | 2016-02-17 |
| 190925 | 2010418303 | K131928 | FREND TSH (REAGENT CARTRIDGE) | JLW | 2014-03-14 |
| 190925 | 2004507500 | K124056 | FREND PSA PLUS (REAGENT CARTRIDGE) | LTJ | 2013-05-29 |
| 190925 | 1538248407 | K053452 | PURE-AID PREGNANCY TEST | LCX | 2006-05-25 |
| 190925 | 1965124015 | BK261351 | |||
| 190925 | 1232706589 | BK231031 | |||
| 190925 | 1752018513 | BK210621 | |||
| 190925 | 1688958343 | BK200525 | |||
| 190925 | 1445010298 | BK180283 | |||
| 190925 | 1906043644 | BK120068 | |||
| 190925 | 1263774033 | BK120015 | |||
| 190925 | 1717863790 | ||||
| 190925 | 1155854415 | ||||
| 190925 | 1180020665 | ||||
| 190925 | 1285180323 | ||||
| 190925 | 1487549922 | ||||
| 190925 | 1496618193 | ||||
| 190925 | 1516818256 | ||||
| 190925 | 1720265085 | ||||
| 190925 | 1758011481 | ||||
| 190925 | 1967812997 | ||||
| 190925 | 2056061178 |