|
Device | ELECSYS TOTAL PSA IMMUNOASSAY |
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 | S010 |
Date Received | 10/07/2009 |
Decision Date | 12/03/2009 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INTRODUCTION OF A LARGER TEST KIT WITH 200 DETERMINATIONS INSTEAD OF 100 DETERMINATIONS. |