Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K121003 |
Device Name |
ABBOTT PLEX-ID FLU ASSAY |
Applicant |
ABBOTT LABORATORIES |
1300 EAST TOUHY AVENUE |
DES PLAINES,
IL
60018
|
|
Applicant Contact |
DARREN CLARKE |
Correspondent |
ABBOTT LABORATORIES |
1300 EAST TOUHY AVENUE |
DES PLAINES,
IL
60018
|
|
Correspondent Contact |
DARREN CLARKE |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/02/2012 |
Decision Date | 12/21/2012 |
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
|
|
|