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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.
 
DeviceGAMMA DAB (125I) AFP RIA KIT
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namekit, test, alpha-fetoprotein for neural tube defects
Applicant
INCSTAR CORP.
1990 insustrial blvd.
p.o. box 285
stillwater, MN 55082-0285
PMA NumberP790032
Supplement NumberS001
Date Received06/10/1986
Decision Date08/22/1986
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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