Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K121842 |
Device Name |
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C |
Applicant |
AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
DUNDEE, SCOTLAND,
GB
DD2 1XA
|
|
Applicant Contact |
CLAIRE I DORA |
Correspondent |
AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
DUNDEE, SCOTLAND,
GB
DD2 1XA
|
|
Correspondent Contact |
CLAIRE I DORA |
Regulation Number | 864.7470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/25/2012 |
Decision Date | 12/12/2012 |
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
|
|
|