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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.
 
DeviceTANDEM(R)-E AFP
Generic NameKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Regulation Number866.6010
ApplicantBeckman Coulter, Inc.
7330 Carroll Rd.
P.O. Box 269006
San Diego, CA 92196
PMA NumberP840035
Supplement NumberS007
Date Received05/06/1988
Decision Date06/03/1988
Product Code LOJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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