Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K001086 |
FOIA Releasable 510(k) |
K001086
|
Device Name |
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 |
Applicant |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. |
WEBSTER,
TX
77598
|
|
Applicant Contact |
JOHN CLASS |
Correspondent |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. |
WEBSTER,
TX
77598
|
|
Correspondent Contact |
JOHN CLASS |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 04/04/2000 |
Decision Date | 05/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|