|
Device | ELECSYS FREE PSA IMMUNOASSAY |
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 | S018 |
Date Received | 04/09/2013 |
Decision Date | 03/21/2014 |
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 THE SOFTWARE CHANGE FROM VERSION 06-07 TO 06-08 ON THEELECSYS 2010 ANALYZER TO CORRECT THE POSSIBILITY OF INCORRECT RESULTS AFTER AUTOMATIC DILUTION. |