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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ige, antigen, antiserum, control
510(k) Number K991316
Device Name TOUCH TEAR IGE MICROASSAY KIT
Applicant
TOUCH SCIENTIFIC, INC.
3209 GRESHAM LAKE RD.
SUITE 112
raleigh,  NC  27615
Applicant Contact alan j touch
Correspondent
TOUCH SCIENTIFIC, INC.
3209 GRESHAM LAKE RD.
SUITE 112
raleigh,  NC  27615
Correspondent Contact alan j touch
Regulation Number866.5510
Classification Product Code
DGC  
Date Received04/19/1999
Decision Date 08/09/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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