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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAMERSHAM AFP
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namealpha-fetoprotein ria diagnostic kit
ApplicantEASTMAN KODAK COMPANY
PMA NumberP780006
Date Received10/12/1978
Decision Date06/07/1984
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 84M-0227
Notice Date 07/06/1984
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S002 S003 
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