|
Device | IMX AND AXSYM PSA |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. ABBOTT PARK, IL 60064-3500 |
PMA Number | P910007 |
Supplement Number | S008 |
Date Received | 03/18/2002 |
Decision Date | 09/05/2002 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED. |