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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lactoferrin, antigen, antiserum, control
510(k) Number K931901
Device Name LACTOCARD
Original Applicant
TOUCH SCIENTIFIC, INC.
3209 gresham lake rd.
suite 112
raleigh,  NC  27615
Original Contact pierce youngbar
Regulation Number866.5570
Classification Product Code
DEG  
Date Received04/19/1993
Decision Date 07/06/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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