Device Classification Name |
system, test, genotypic detection, resistant markers, staphylococcus colonies
|
510(k) Number |
K121905 |
Device Name |
ALERE PBP2A TEST |
Applicant |
ALERE SCARBOROUGH, INC |
10 Southgate Road |
Scarborough,
ME
04074
|
|
Applicant Contact |
Angela Drysdale |
Correspondent |
ALERE SCARBOROUGH, INC |
10 Southgate Road |
Scarborough,
ME
04074
|
|
Correspondent Contact |
Angela Drysdale |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 06/29/2012 |
Decision Date | 07/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|