Company · US
Nanoentek USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2017. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2017 | K162378 | FREND PSA PLUS (reagent cartridge) Nanoentek USA, Inc. | LTJ |
| Jan 12, 2017 | K162754 | FREND Vitamin D Test System Nanoentek USA, Inc. | MRG |
| Oct 14, 2016 | K153577 | FREND Testosterone Test System Nanoentek USA, Inc. | CDZ |
| Feb 17, 2016 | K152422 | FREND Free T4 Test System Nanoentek USA, Inc. | CEC |
| Mar 14, 2014 | K131928 | FREND TSH (REAGENT CARTRIDGE) Nanoentek USA, Inc. | JLW |
| May 29, 2013 | K124056 | FREND PSA PLUS (REAGENT CARTRIDGE) Nanoentek, Inc. | LTJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||