Device Classification Name |
real time nucleic acid amplification system
|
510(k) Number |
K151690 |
Device Name |
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A |
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 | 862.2570
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/23/2015 |
Decision Date | 07/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|