|
Device | ELECSYS FREE PSA CALCHECK |
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 | S020 |
Date Received | 11/25/2014 |
Decision Date | 12/22/2014 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement RELOCATION OF THE FINAL KIT ASSEMBLY AND LABELING OPERATIONS TO A NEW BUILDING WITHIN THE SAME FACILITY. |