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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 NameGAMMA DAB (125I) AFP RIA KIT
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Nameafp-ria diagnostic kit
ApplicantINCSTAR CORP.
PMA NumberP790032
Date Received12/21/1979
Decision Date04/30/1986
Withdrawal Date 08/19/2002
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 86M-0206
Notice Date 06/17/1986
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 
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