Device Classification Name |
radioimmunoassay, parathyroid hormone
|
510(k) Number |
K053533 |
Device Name |
IMMULITE/IMMULITE 1000 TURBO INTACT PTH |
Applicant |
DIAGNOSTIC PRODUCTS CORPORATION |
5210 PACIFIC CONCOURSE DR. |
LOS ANGELES,
CA
90045 -6900
|
|
Applicant Contact |
DEBORAH L MORRIS |
Correspondent |
DIAGNOSTIC PRODUCTS CORPORATION |
5210 PACIFIC CONCOURSE DR. |
LOS ANGELES,
CA
90045 -6900
|
|
Correspondent Contact |
DEBORAH L MORRIS |
Regulation Number | 862.1545
|
Classification Product Code |
|
Date Received | 12/19/2005 |
Decision Date | 02/03/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|