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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 NameAUTODELFIA HAFP TEST KIT
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantWALLAC OY
PMA NumberP970037
Supplement NumberS001
Date Received10/18/2002
Decision Date11/27/2002
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the patient and physician brochures and 3 versions of the package insert for the laboratory.
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