|
Device | DIMENSIONS TPSA FLE REAGENT CARTRIDGE |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P000021 |
Supplement Number | S017 |
Date Received | 07/06/2010 |
Decision Date | 09/02/2010 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF A CLOT CHECK DEVICE TO THE DIMENSION EXL WITH LM SYSTEM WHEN USED WITH THE DIMENSION TPSA FLEX REAGENT CARTRIDGE. |