The following data is part of a premarket notification filed by Nanoentek Usa Inc. with the FDA for Frend Testosterone Test System.
| Device ID | K153577 |
| 510k Number | K153577 |
| Device Name: | FREND Testosterone Test System |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | NanoEnTek USA Inc. 5627 Stoneridge Drive Suite 304 Pleasanton, CA 94588 |
| Contact | Jimmy Chen |
| Correspondent | Maureen N Garner New World Regulatory Solutions Inc. 1983 Hazelwood Road Toms River, NJ 08753 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-15 |
| Decision Date | 2016-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809317540375 | K153577 | 000 |
| 08809317540153 | K153577 | 000 |