Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K071466 |
Device Name |
DCA VANTAGE, MODEL 5075 |
Applicant |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
2 EDGEWATER DR. |
NORWOOD,
MA
02062
|
|
Applicant Contact |
NOOR MALKI |
Correspondent |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
2 EDGEWATER DR. |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
NOOR MALKI |
Regulation Number | 864.7470
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/29/2007 |
Decision Date | 10/09/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|