|
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 | S011 |
Date Received | 05/03/2011 |
Decision Date | 09/23/2011 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY. |