Device Classification Name |
Extractable Antinuclear Antibody, Antigen And Control
|
510(k) Number |
K190710 |
Device Name |
EliA SymphonyS Immunoassay |
Applicant |
Phadia AB |
Rapsgatan 7P |
Uppsala,
SE
SE 754 50
|
|
Applicant Contact |
Carina Magnusson |
Correspondent |
Phadia US Inc. |
4169 Commercial Avenue |
Portage,
MI
49002
|
|
Correspondent Contact |
Sheryl Skinner |
Regulation Number | 866.5100
|
Classification Product Code |
|
Date Received | 03/19/2019 |
Decision Date | 11/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|