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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 NameIMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Namepsa test kit
Regulation Number866.6010
ApplicantDIAGNOSTIC PRODUCTS CORP.
PMA NumberP930027
Supplement NumberS004
Date Received01/02/2001
Decision Date06/19/2001
Product Code
LTJ[ Registered Establishments with LTJ ]
Docket Number 01M-0535
Notice Date 12/05/2001
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Immulite psa, immulite. Third generation psa, immulite 2000 psa, and immulite 2000 third generation psa. Immulite. Psa is indicated for in vitro diagnostic use with the immulite analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years or older. Immulite third generation psa is indicated for in vitro diagnostic use with the immulite analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years or older. Immulite 2000 psa is indicated for in vitro diagnostic use with the immulite 2000 analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years or older. Immulite 2000 third generation psa is indicated for in vitro diagnostic use with the immulite 2000 analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years of older.
Approval Order Approval Order
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