|Trade Name||IMMULITE/IMMULITE 2000 AFP|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Applicant||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for introduction of a new instrument model immulite 2000 xpi analyzer, as a family member of the currently cleared immulite 2000 analyzer.