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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K874168
Device Name IVT SOUTHEAST ALLERGY SCREEN
Applicant
In Vitro Technologies, Inc.
2100 Rd. To Six Flags, E.
P.O. Box 202003
Arlington,  TX  76011
Applicant Contact BEN CARD
Correspondent
In Vitro Technologies, Inc.
2100 Rd. To Six Flags, E.
P.O. Box 202003
Arlington,  TX  76011
Correspondent Contact BEN CARD
Regulation Number866.5750
Classification Product Code
DHB  
Date Received10/13/1987
Decision Date 01/11/1988
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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