|Trade Name||ELECSYS TOTAL PSA|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Generic Name||electrochemiluminescence assay for the determination of prostate specific antigen;psa calibrator|
|Applicant||ROCHE DIAGNOSTICS CORP.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Transfer the rework location from building r to a connected building w2 on the indianapolis campus for the device.