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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 RXL MAX TPSA FLEX REAGENT CARTRIDGE
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
po box 6101
newark, DE 19714-6101
PMA NumberP000021
Supplement NumberS014
Date Received04/06/2009
Decision Date06/04/2009
Product Code
MTF[ Registered Establishments with MTF ]
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 use of the dimension tpsa flex reagent cartridge on the dimension rxl max with advia modular automation systems (amas) (advia labcell and advia workcell).
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