Device Classification Name |
Radioimmunoassay, Parathyroid Hormone
|
510(k) Number |
K132515 |
Device Name |
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS |
Applicant |
DIASORIN, INC. |
1951 NORTHWESTERN AVE. |
STILLWATER,
MN
55082 -0285
|
|
Applicant Contact |
CAROL A DEPOUW |
Correspondent |
DIASORIN, INC. |
1951 NORTHWESTERN AVE. |
STILLWATER,
MN
55082 -0285
|
|
Correspondent Contact |
CAROL A DEPOUW |
Regulation Number | 862.1545
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/12/2013 |
Decision Date | 11/08/2013 |
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
|
|
|