Device Classification Name |
calibrator, secondary
|
510(k) Number |
K040471 |
Device Name |
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 |
Applicant |
OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. |
IRVING,
TX
75063 -3104
|
|
Applicant Contact |
MICHAEL CAMPBELL |
Correspondent |
OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. |
IRVING,
TX
75063 -3104
|
|
Correspondent Contact |
MICHAEL CAMPBELL |
Regulation Number | 862.1150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/24/2004 |
Decision Date | 03/10/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|