Device Classification Name |
Assay, Glycosylated Hemoglobin
|
510(k) Number |
K102045 |
Device Name |
DIMENSION VISA HBA1C, MODEL K3105A |
Applicant |
SIEMENS HEATLHCARE DIAGNOSTICS INC |
500 GBC DRIVE |
P.O. BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
ANNA-MARIE K ENNIS |
Correspondent |
SIEMENS HEATLHCARE DIAGNOSTICS INC |
500 GBC DRIVE |
P.O. BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
ANNA-MARIE K ENNIS |
Regulation Number | 864.7470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2010 |
Decision Date | 02/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|