Device Classification Name |
analyzer, chemistry (photometric, discrete), for clinical use
|
510(k) Number |
K002982 |
Device Name |
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER |
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 | 862.2160
|
Classification Product Code |
|
Date Received | 09/25/2000 |
Decision Date | 10/25/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|