|
Device | ELECSYS FREE PSA (FPSA) 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 | S012 |
Date Received | 08/01/2011 |
Decision Date | 02/24/2012 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENSION OF THE ELECSYS FREE PSA (FPSA) TEST SYSTEM ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER. |