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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.
 
DeviceAUTODELFIA HAFP KIT
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantRevvity, Inc.
77 4th St.
Waltham, MA 02451
PMA NumberP970037
Supplement NumberS005
Date Received03/17/2011
Decision Date04/08/2011
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN A RAW MATERIAL USED IN THE MANUFACTURE OF THE ENHANCEMENT SOLUTION AUXILIARY REAGENT USED WITH THE AUTODELFIA HAFP KIT.
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