|Trade Name||DIMENSION TPSA FLEX REAGENT CARTRIDGE|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Applicant||SIEMENS HEALTHCARE DIAGNOSTICS INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Discontinuation of an absorbance test performed on nylon-surlyn film and surlyn film prior to release of the film for slitting and cuvette film canister assembly.