Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K002294 |
Device Name |
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 |
Applicant |
BIOCHECK, INC. |
9418 LASAINE AVE. |
NORTHRIDGE,
CA
91325
|
|
Applicant Contact |
ROBIN J HELLEN |
Correspondent |
BIOCHECK, INC. |
9418 LASAINE AVE. |
NORTHRIDGE,
CA
91325
|
|
Correspondent Contact |
ROBIN J HELLEN |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 07/27/2000 |
Decision Date | 10/02/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|