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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP000021
Date Received06/05/2000
Decision Date07/05/2001
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 01M-0310
Notice Date 07/23/2001
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the dimension(r) rxl psa flex(r) reagent cartridge. The device is indicated for the following: the psa method for the dimension(r) clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure prostate specific antigen (psa) in human serum: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. 2) as an aid in the management (monitoring) of prostate cancer patients.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 
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