Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P970038 |
Supplement Number | S008 |
Date Received | 04/10/2006 |
Decision Date | 05/18/2006 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ACCESS PSA REAGENTS FOR USE ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCESS FREE PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM. |
|
|