Device Classification Name |
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
|
510(k) Number |
K220949 |
Device Name |
Architect CMV IgG |
Applicant |
Abbott Laboratories |
Dept 09AA, Bldg. AP8A, 100 Abbott Park Rd. |
Abbott Park,
IL
60064
|
|
Applicant Contact |
Shannon Reibling |
Correspondent |
Abbott Laboratories |
Dept 09AA, Bldg. AP8A, 100 Abbott Park Rd. |
Abbott Park,
IL
60064
|
|
Correspondent Contact |
Shannon Reibling |
Regulation Number | 866.3175
|
Classification Product Code |
|
Date Received | 04/01/2022 |
Decision Date | 10/27/2022 |
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
|
|
|