|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM|
|Applicant||BECKMAN COULTER, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Modification to the quality control prefill and postfill reagent pack procedures.