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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 K914685
Device Name 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS
Applicant
In Vitro Technologies, Inc.
2100 Rd. To Six Flags, E.
P.O. Box 202003
Arlington,  TX  76011
Applicant Contact KENNETH KELLY
Correspondent
In Vitro Technologies, Inc.
2100 Rd. To Six Flags, E.
P.O. Box 202003
Arlington,  TX  76011
Correspondent Contact KENNETH KELLY
Regulation Number866.5750
Classification Product Code
DHB  
Date Received10/18/1991
Decision Date 09/14/1992
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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