Device Classification Name |
respiratory virus panel nucleic acid assay system
|
510(k) Number |
K153544 |
Device Name |
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System |
Applicant |
IQuum, Inc. |
700 Nickerson Road |
Marlborough,
MA
01752
|
|
Applicant Contact |
Lingjun Chen |
Correspondent |
IQuum, Inc. |
4300 Hacienda Drive |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
David W Gates |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/11/2015 |
Decision Date | 07/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Dual Track
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|