Device Classification Name |
respiratory virus panel nucleic acid assay system
|
510(k) Number |
K131584 |
Device Name |
IMDX FLU A/B AND RSV FOR ABBOTT M2000 |
Applicant |
INTELLIGENT MEDICAL DEVICES, INC |
180 CABOT ST. |
BEVERLY,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
INTELLIGENT MEDICAL DEVICES, INC |
180 CABOT ST. |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/31/2013 |
Decision Date | 08/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|