Device Classification Name |
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
|
510(k) Number |
K200236 |
Device Name |
VITROS BRAHMS PCT Reagent Pack and Calibrators |
Applicant |
Ortho Clinical Diagnostics |
100 Indigo Creek Drive |
Rochester,
NY
14626
|
|
Applicant Contact |
Ann M Quinn |
Correspondent |
Ortho Clinical Diagnostics |
100 Indigo Creek Drive |
Rochester,
NY
14626
|
|
Correspondent Contact |
Ann M Quinn |
Regulation Number | 866.3215
|
Classification Product Code |
|
Date Received | 01/30/2020 |
Decision Date | 02/25/2020 |
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
|