Device Classification Name |
myoglobin, antigen, antiserum, control
|
510(k) Number |
K122599 |
Device Name |
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR |
Applicant |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
KIRA GORDON |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
KIRA GORDON |
Regulation Number | 866.5680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/27/2012 |
Decision Date | 10/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|