|
Device | DIMENSION PSA FLEX REAGENT CARTRIDGE |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P000021 |
Supplement Number | S001 |
Date Received | 07/12/2001 |
Decision Date | 07/31/2001 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE DIMENSION(R) PSA FLEX(R) REAGENT CARTRIDGE FOR USE WITH THE DIMENSION(R) XPAND(TM) SYSTEM. |