|
Device | ARCHITECT TOTAL PSA (LN 6C06) |
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 | S045 |
Date Received | 06/02/2014 |
Decision Date | 06/18/2014 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO THE QUALITY CONTROL TESTING OF ARCHITECT FREE PSA PANELS G/I, ARCHITECT TOTAL PSA PANEL STOCK AND ARCHITECT TOTAL PSA PANELS K/Q. |