|
Device | Elecsys total PSA Test System |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P990056 |
Supplement Number | S036 |
Date Received | 01/29/2019 |
Decision Date | 05/03/2019 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of K2-EDTA plasma as an approved sample type for the Elecsys total PSA and Elecsys free PSA test systems. |