Device Classification Name |
analyzer, chemistry (photometric, discrete), for clinical use
|
510(k) Number |
K130276 |
Device Name |
DIMENSION EXL WITH LM SYSTEM |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
500 GBC DRIVE M/S 514 |
P.O. BOX 6101 |
NEWARK,
DE
19714 -3026
|
|
Applicant Contact |
PAMELA A JURGA |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
500 GBC DRIVE M/S 514 |
P.O. BOX 6101 |
NEWARK,
DE
19714 -3026
|
|
Correspondent Contact |
PAMELA A JURGA |
Regulation Number | 862.2160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/05/2013 |
Decision Date | 03/22/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|