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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
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 NumberS003
Date Received02/26/1991
Decision Date07/23/1993
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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