Device Classification Name |
Radioimmunoassay, Parathyroid Hormone
|
510(k) Number |
K033727 |
Device Name |
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY |
Applicant |
NICHOLS INSTITUTE DIAGNOSTICS |
1311 CALLE BATIDO |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
ROBERT L SCHMIDT |
Correspondent |
NICHOLS INSTITUTE DIAGNOSTICS |
1311 CALLE BATIDO |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
ROBERT L SCHMIDT |
Regulation Number | 862.1545
|
Classification Product Code |
|
Date Received | 11/28/2003 |
Decision Date | 04/22/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|