Device Classification Name |
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
|
510(k) Number |
K121907 |
Device Name |
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
P.O. BOX 6101, MAILSTAP 514 |
NEWARK,
DE
19714
|
|
Applicant Contact |
ROSE T MARINELLI |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
P.O. BOX 6101, MAILSTAP 514 |
NEWARK,
DE
19714
|
|
Correspondent Contact |
ROSE T MARINELLI |
Regulation Number | 862.1050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/29/2012 |
Decision Date | 07/23/2012 |
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
|
|
|