Device Classification Name |
radioimmunoassay, androstenedione
|
510(k) Number |
K934751 |
Device Name |
ACTIVE ANDROSTANEDIOL GLUCURONIDE |
Applicant |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. |
WEBSTER,
TX
77598
|
|
Applicant Contact |
WILLIAM TAYLOR |
Correspondent |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. |
WEBSTER,
TX
77598
|
|
Correspondent Contact |
WILLIAM TAYLOR |
Regulation Number | 862.1075
|
Classification Product Code |
|
Date Received | 10/04/1993 |
Decision Date | 01/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|