Device Classification Name |
Radioimmunoassay, Cortisol
|
510(k) Number |
K850141 |
Device Name |
ACTIVE CORTISOL DSL 2000-SP |
Applicant |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. |
WEBSTER,
TX
77598
|
|
Applicant Contact |
GOPAL SAVJANI |
Correspondent |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. |
WEBSTER,
TX
77598
|
|
Correspondent Contact |
GOPAL SAVJANI |
Regulation Number | 862.1205
|
Classification Product Code |
|
Date Received | 01/14/1985 |
Decision Date | 02/06/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|