Device Classification Name |
Procalcitonin Assay
|
510(k) Number |
K173927 |
Device Name |
Elecsys BRAHMS PCT |
Applicant |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
Wes Gerbig |
Correspondent |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Wes Gerbig |
Regulation Number | 866.3215
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/26/2017 |
Decision Date | 07/06/2018 |
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
|
|
|