Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K152422 |
Device Name |
FREND™ Free T4 Test System |
Applicant |
NANOENTEK USA INC |
5627 STONERIDGE DRIVE SUITE 304 |
PLEASANTON,
CA
94588
|
|
Applicant Contact |
JIMMY CHEN |
Correspondent |
NEW WORLD REGULATORY SOLUTIONS, INC. |
1983 HAZELWOOD ROAD |
TOMS RIVER,
NJ
08753
|
|
Correspondent Contact |
MAUREEN GARNER |
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 08/26/2015 |
Decision Date | 02/17/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|