The following data is part of a premarket notification filed by Nanoentek Usa Inc with the FDA for Frend Psa Plus (reagent Cartridge).
| Device ID | K162378 |
| 510k Number | K162378 |
| Device Name: | FREND PSA PLUS (reagent Cartridge) |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | NANOENTEK USA INC 5627 STONERIDGE DRIVE SUITE 304 Pleasanton, CA 94588 |
| Contact | Sunmi Han |
| Correspondent | Sunmi Han NANOENTEK USA INC 5627 STONERIDGE DRIVE SUITE 304 Pleasanton, CA 94588 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-24 |
| Decision Date | 2017-05-17 |
| Summary: | summary |