Device Classification Name |
Procalcitonin Assay
|
510(k) Number |
K172713 |
Device Name |
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set |
Applicant |
Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway |
Malvern,
PA
19355
|
|
Applicant Contact |
Stacey Dolan |
Correspondent |
Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway |
Malvern,
PA
19355
|
|
Correspondent Contact |
Stacey Dolan |
Regulation Number | 866.3215
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/08/2017 |
Decision Date | 12/10/2017 |
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
|
|
|