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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.
 
DeviceACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantBeckman Coulter, Inc.
250 S. Kraemer Blvd. M/S
W-110
Brea, CA 92822
PMA NumberP980041
Supplement NumberS011
Date Received02/26/2008
Decision Date03/26/2008
Product Code LOK 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A WARNING REGARDING THE CONCENTRATION OF PROCLIN 300 IN THE ACCESS AFP SAMPLE DILUENT IN THE PRODUCT LABELING.
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