Device Classification Name |
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
|
510(k) Number |
K222736 |
Device Name |
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay |
Applicant |
Hologic, Inc. |
10210 Genetic Center Drive |
San Diego,
CA
92121
|
|
Applicant Contact |
Vlada Rudenko |
Correspondent |
Hologic, Inc. |
10210 Genetic Center Drive |
San Diego,
CA
92121
|
|
Correspondent Contact |
Vlada Rudenko |
Regulation Number | 866.3981
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/09/2022 |
Decision Date | 05/16/2023 |
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
|
Recalls |
CDRH Recalls
|
|
|