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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.
 
DeviceIMMULITE/IMMULITE 2000 FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
glyn rhonwy. llanberis
caernarfon
gwynedd, ll55 4EL
PMA NumberP060005
Supplement NumberS004
Date Received02/18/2011
Decision Date04/26/2011
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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