|
Device | ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY 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 | S016 |
Date Received | 03/15/2012 |
Decision Date | 04/13/2012 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR NEW INFORMATION TO BE ADDED TO THE INSTRUCTIONS FOR USE, THE OPERATORS GUIDE AND THE REFERENCE MANUAL, INCLUDING THE FOLLOWING: 1) ADD INSTRUCTIONS TO THE WEEKLY MAINTENANCE SECTIONS OF THESE DOCUMENTS FOR THE INSPECTION OF THE LIQUID WASTE BOTTLES; 2) CLARIFY PACK MIXING INSTRUCTIONS; 3) ADD TROUBLESHOOTING STEPS; 4) CHANGE CAUTIONS INTO WARNINGS; AND 5) CHANGE NOTES INTO WARNINGS. |