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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 1000 PSA & 1000 THIRD GENERATION PSA
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
glyn rhonwy, llanberis
gwynedd ll55 4el LL554
PMA NumberP930027
Supplement NumberS005
Date Received01/21/2003
Decision Date02/28/2003
Product Code
LTJ[ Registered Establishments with LTJ ]
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 the addition of the immulite 1000 analyzer to the analyzers used for the immulite psa and immulite third generation psa assays.
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