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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.
 
DeviceDIMENSION FPSA FLEX REAGENT CARTRIDGE
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 HEALTHCARE DIAGNOSTICS
500 gbc drive, p o box 6101
m/s 514
newark, DE 19714-6101
PMA NumberP020027
Supplement NumberS017
Date Received02/01/2012
Decision Date03/22/2012
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 a software revision that changes the operating system of the instrument from the current qnx operating system to the linux operating system and addresses hardware obsolescence issues.
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