Device Classification Name |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
|
510(k) Number |
K112999 |
Device Name |
DIMENSION CLINICAL CHEMISTRY SYSTEM |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
P.O. BOX 6101 |
MIALSTOP 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
LORRAINE H PIESTRAK |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
P.O. BOX 6101 |
MIALSTOP 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
LORRAINE H PIESTRAK |
Regulation Number | 862.2160
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/07/2011 |
Decision Date | 11/22/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|