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 | ARCHITECT TOTAL PSA |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. ABBOTT PARK, IL 60064-3500 |
PMA Number | P910007 |
Supplement Number | S043 |
Date Received | 04/16/2014 |
Decision Date | 05/16/2014 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REVISION OF THE QUALITY CONTROL TEST METHOD TO ALLOW THE AXSYM TOTAL AND FREE PSA TEST METHODS TO BE REPLACED BY THE ARCHITECT TOTAL AND FREE PSA TEST METHODS FOR THE MANUFACTURE OF PSA PANEL H. |
|
|