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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 KIT
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantRevvity, Inc.
77 4th St.
Waltham, MA 02451
PMA NumberP970037
Supplement NumberS001
Date Received10/18/2002
Decision Date11/27/2002
Product Code LOK 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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