Device Classification Name |
serpina1 variant detection system
|
510(k) Number |
K192858 |
Device Name |
A1AT Genotyping Test |
Applicant |
Progenika Biopharma S.A., A Grifols Company |
Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia |
Derio,
ES
48160
|
|
Applicant Contact |
Diego Tejedor |
Correspondent |
Progenika Biopharma S.A., A Grifols Company |
Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia |
Derio,
ES
48160
|
|
Correspondent Contact |
Diego Tejedor |
Regulation Number | 866.5130
|
Classification Product Code |
|
Date Received | 10/04/2019 |
Decision Date | 11/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|