FREND™ Free T4 Test System
Radioimmunoassay, Free Thyroxine
NANOENTEK USA INC
The following data is part of a premarket notification filed by Nanoentek Usa Inc with the FDA for Frend™ Free T4 Test System.
Pre-market Notification Details
| Device ID | K152422 |
| 510k Number | K152422 |
| Device Name: | FREND™ Free T4 Test System |
| Classification | Radioimmunoassay, Free Thyroxine |
| 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 | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-26 |
| Decision Date | 2016-02-17 |
| Summary: | summary |
Trademark Results [FREND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREND 85028377 not registered Dead/Abandoned |
Home Dialysis Plus, Ltd. 2010-05-03 |
 FREND 79116983 4303411 Live/Registered |
NANOENTEK, INC. 2012-02-02 |
 FREND 77781495 not registered Dead/Abandoned |
Dane Lee Gabriel 2009-07-15 |
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