Device Classification Name |
Radioimmunoassay, Human Growth Hormone
|
510(k) Number |
K950228 |
Device Name |
DSL ACTIVE IGFBP-3 IRMA (DSL 6600) |
Applicant |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. |
WEBSTER,
TX
77598
|
|
Applicant Contact |
JOHN WILLIS |
Correspondent |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. |
WEBSTER,
TX
77598
|
|
Correspondent Contact |
JOHN WILLIS |
Regulation Number | 862.1370
|
Classification Product Code |
|
Date Received | 01/11/1995 |
Decision Date | 02/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|