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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 K934473
Device Name LACTOFERRIN MICROASSAY SYSTEM
Applicant
TOUCH SCIENTIFIC, INC.
3209 GRESHAM LAKE RD.
SUITE 112
RALEIGH,  NC  27615
Applicant Contact PIERCE R YOUNGBAR
Correspondent
TOUCH SCIENTIFIC, INC.
3209 GRESHAM LAKE RD.
SUITE 112
RALEIGH,  NC  27615
Correspondent Contact PIERCE R YOUNGBAR
Regulation Number866.5570
Classification Product Code
DEG  
Date Received09/14/1993
Decision Date 12/03/1993
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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