Device Classification Name |
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
|
510(k) Number |
K160729 |
FOIA Releasable 510(k) |
K160729
|
Device Name |
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 |
Applicant |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
Adam Clark |
Correspondent |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Adam Clark |
Regulation Number | 866.3215
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/16/2016 |
Decision Date | 06/13/2016 |
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
|
|
|