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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDIMENSIONS TPSA FLE 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 NumberS017
Date Received07/06/2010
Decision Date09/02/2010
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 ADDITION OF A CLOT CHECK DEVICE TO THE DIMENSION EXL WITH LM SYSTEM WHEN USED WITH THE DIMENSION TPSA FLEX REAGENT CARTRIDGE.
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