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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.
 
DeviceIMMULITE(R) THIRD GENERATION PSA
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
glyn rhonwy, llanberis
gwynedd ll55 4el LL554
PMA NumberP930027
Supplement NumberS001
Date Received10/18/1995
Decision Date07/11/1996
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGING THE COAT-A-COUNT PSA IRMA FROM AN IMMUNORADIOMETRIC TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM TO A SOLID PHASE, TWO-SITE CHEMILUMINESCENT IMMUNOMETRIC ASSAY FOR USE ON THE IMMULITE AUTMOATED IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE PSA
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