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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 K874541
Device Name RRT TOTAL IGE TEST KIT
Applicant
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact LISA J STONE
Correspondent
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact LISA J STONE
Regulation Number866.5510
Classification Product Code
DGC  
Date Received11/03/1987
Decision Date 02/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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