Device Classification Name |
Radioimmunoassay, Parathyroid Hormone
|
510(k) Number |
K013992 |
Device Name |
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY |
Applicant |
NICHOLS INSTITUTE DIAGNOSTICS |
33051 CALLE AVIADOR |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Applicant Contact |
ROBERT SCHMIDT |
Correspondent |
CALIFORNIA DEPARTMENT OF HEALTH SERVICES |
P.O. BOX 942732 (MS-357) |
SACRAMENTO,
CA
94234 -7320
|
|
Correspondent Contact |
RAYMOND WILSON |
Regulation Number | 862.1545
|
Classification Product Code |
|
Date Received | 12/04/2001 |
Decision Date | 12/13/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|