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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Rna Preservative For Collection, Storage, And Transportation
510(k) Number K113420
Device Name RNARETAIN
Applicant
Asuragen, Inc.
2150 Woodward St., Suite 100
Austin,  TX  78744
Applicant Contact Luc Van Hove
Correspondent
Asuragen, Inc.
2150 Woodward St., Suite 100
Austin,  TX  78744
Correspondent Contact Luc Van Hove
Regulation Number866.4070
Classification Product Code
OZF  
Date Received11/18/2011
Decision Date 03/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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