Device Classification Name |
calibrator, secondary
|
510(k) Number |
K081789 |
Device Name |
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR |
Applicant |
Siemens Healthcare Diagnostics Inc. |
500 GBC DRIVE |
MS 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
HELEN M LEE |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
500 GBC DRIVE |
MS 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
HELEN M LEE |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 06/25/2008 |
Decision Date | 09/10/2008 |
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
|
|
|