Device Classification Name |
radioimmunoassay, thyroid-stimulating hormone
|
510(k) Number |
K062581 |
Device Name |
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM |
Applicant |
OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. |
IRVING,
TX
75063 -3104
|
|
Applicant Contact |
DAVID DAVIS |
Correspondent |
OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. |
IRVING,
TX
75063 -3104
|
|
Correspondent Contact |
DAVID DAVIS |
Regulation Number | 862.1690
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/31/2006 |
Decision Date | 11/29/2006 |
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
|
|
|