Device Classification Name |
respiratory virus panel nucleic acid assay system
|
510(k) Number |
K143653 |
Device Name |
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) |
Applicant |
NANOSPHERE, INC |
4088 COMMERCIAL AVENUE |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
Noah Lermer |
Correspondent |
MDC ASSOCIATES, LLC |
180 Cabot Street |
Beverly,
MA
01915
|
|
Correspondent Contact |
Fran White |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/2014 |
Decision Date | 09/04/2015 |
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
|
Recalls |
CDRH Recalls
|
|
|