Device Classification Name |
autoantibodies, endomysial(tissue transglutaminase)
|
510(k) Number |
K193604 |
Device Name |
Aptiva Celiac Disease IgA Reagent |
Applicant |
Inova Diagnostics, Inc. |
9900 Old Grove Road |
San Diego,
CA
92131 -1638
|
|
Applicant Contact |
Andrea Seaman |
Correspondent |
Inova Diagnostics, Inc. |
9900 Old Grove Road |
San Diego,
CA
92131 -1638
|
|
Correspondent Contact |
Ronda Elliott |
Regulation Number | 866.5660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/2019 |
Decision Date | 06/16/2021 |
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
|
|
|