Device Classification Name |
Zika Virus Serological Reagents
|
510(k) Number |
K192046 |
Device Name |
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set |
Applicant |
DiaSorin Inc. |
1951 Northwestern Ave. |
Stillwater,
MN
55082 -0285
|
|
Applicant Contact |
John C. Walter |
Correspondent |
DiaSorin Inc. |
1951 Northwestern Avenue |
Stillwater,
MN
55082 -0285
|
|
Correspondent Contact |
Sandra Zimniewicz |
Classification Product Code |
|
Date Received | 07/31/2019 |
Decision Date | 10/28/2019 |
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
|