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 |