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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 TEST SYSTEM
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantRevvity, Inc.
77 4th St.
Waltham, MA 02451
PMA NumberP970037
Supplement NumberS009
Date Received07/27/2016
Decision Date08/23/2016
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modification of two of the incoming quality control test methods performed for the bovine serum albumin (BSA) raw material and Change of the environmental ISO classification.
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