Device Classification Name |
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
|
510(k) Number |
K221460 |
Device Name |
BioFire COVID-19 Test 2 |
Applicant |
BioFire Defense, LLC |
79 W 4500 S, Suite 14 |
Salt Lake City,
UT
84107
|
|
Applicant Contact |
Cynthia Phillips |
Correspondent |
BioFire Defence, LLC |
79 W 4500 S, Suite 14 |
Salt Lake City,
UT
84107
|
|
Correspondent Contact |
Cynthia Phillips |
Regulation Number | 866.3981
|
Classification Product Code |
|
Date Received | 05/19/2022 |
Decision Date | 07/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|