Device Classification Name |
Radioimmunoassay, Parathyroid Hormone
|
510(k) Number |
K973514 |
Device Name |
ACTIVE INTACT PTH |
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 | 862.1545
|
Classification Product Code |
|
Date Received | 09/17/1997 |
Decision Date | 10/31/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|