|
Device | Elecsys free PSA Test System |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P000027 |
Supplement Number | S034 |
Date Received | 01/29/2019 |
Decision Date | 05/03/2019 |
Product Code |
MTG |
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. |