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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 AFP ASSAY
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP010007
Supplement NumberS009
Date Received05/30/2012
Decision Date11/08/2012
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for eliminating the test redundancy by using only the biorad lyphocheck immunoassay plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of immulite afp, free psa, and psa/3rd generation psa assay performance.
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