Device Classification Name |
nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna
|
510(k) Number |
K212778 |
Device Name |
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) |
Applicant |
Abbott Molecular, Inc. |
1300 E. Touhy Ave |
Des Plaines,
IL
60018
|
|
Applicant Contact |
Gina Sammarco |
Correspondent |
Abbott Molecular, Inc. |
1300 E. Touhy Ave |
Des Plaines,
IL
60018
|
|
Correspondent Contact |
Gina Sammarco |
Regulation Number | 866.3183
|
Classification Product Code |
|
Date Received | 09/01/2021 |
Decision Date | 07/15/2022 |
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
|
|
|