Device Classification Name |
radioimmunoassay, thyroid-stimulating hormone
|
510(k) Number |
K063437 |
Device Name |
ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 |
Applicant |
MONOBIND, INC. |
100 N. POINTE DR. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
JAY SINGH |
Correspondent |
MONOBIND, INC. |
100 N. POINTE DR. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
JAY SINGH |
Regulation Number | 862.1690
|
Classification Product Code |
|
Date Received | 11/14/2006 |
Decision Date | 04/04/2008 |
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
|
|
|