Device Classification Name |
radioimmunoassay, parathyroid hormone
|
510(k) Number |
K934760 |
Device Name |
IMMUNLITE INTACT PTH |
Applicant |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Applicant Contact |
KENNETH B ASARCH |
Correspondent |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Correspondent Contact |
KENNETH B ASARCH |
Regulation Number | 862.1545
|
Classification Product Code |
|
Date Received | 10/04/1993 |
Decision Date | 12/10/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|