Device Classification Name |
ferritin, antigen, antiserum, control
|
510(k) Number |
K191562 |
Device Name |
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor |
Applicant |
HORIBA ABX SAS |
Parc Euromedecine, Rue Du Caducee BP7290 |
Montpellier Cedex 4,
FR
341184
|
|
Applicant Contact |
Caroline Ferrer |
Correspondent |
HORIBA ABX SAS |
Parc Euromedecine, Rue Du Caducee BP7290 |
Montpellier Cedex 4,
FR
341184
|
|
Correspondent Contact |
Caroline Ferrer |
Regulation Number | 866.5340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/13/2019 |
Decision Date | 03/06/2020 |
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
|
|
|