Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K093930 |
FOIA Releasable 510(k) |
K093930
|
Device Name |
DIDGET WORLD REPORTS |
Applicant |
BAYER HEALTHCARE LLC |
777 OLD SAW MILL RIVER ROAD |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
SUSAN BROCCHI |
Correspondent |
BAYER HEALTHCARE LLC |
777 OLD SAW MILL RIVER ROAD |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
SUSAN BROCCHI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2009 |
Decision Date | 03/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Clinical Trials |
NCT00923975
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|