|
Device | Elecsys free PSA, free PSA Calset, free PSA CalCheck |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P000027 |
Supplement Number | S023 |
Date Received | 09/07/2016 |
Decision Date | 03/02/2017 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modification to the proprietary device names. |