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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.
 
Trade NameACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Namekit, test, prostate specific antigen
Regulation Number866.6010
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS017
Date Received08/19/2002
Decision Date11/27/2002
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the access hybritech psa on the access 2 immunoassay analyzer. The device is indicated for: the access hybritech psa assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (psa) in human serum using the access immunoassy systems. The device is indicated for the measurement of serum psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for diagnosis of cancer. The device is further indicated for the serial measurement of psa to aid in the prognosis and management of patients with prostate cancer.
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