The following data is part of a premarket notification filed by Nanoentek Usa, Inc. with the FDA for Frend Vitamin D Test System.
| Device ID | K162754 |
| 510k Number | K162754 |
| Device Name: | FREND Vitamin D Test System |
| Classification | System, Test, Vitamin D |
| Applicant | NanoEnTek USA, Inc. 5627 Stoneridge Drive Suite 304 Pleasanton, CA 94588 |
| Contact | Jimmy Chen |
| Correspondent | Maureen Garner New World Regulatory Solutions, Inc. 1983 Hazelwood Road Toms River, NJ 08753 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-01-12 |
| Summary: | summary |