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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameIMMULITE/IMMULITE 2000 PSA
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namepsa test kit
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP930027
Supplement NumberS011
Date Received03/16/2011
Decision Date04/26/2011
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product 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.
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