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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Russel Viper Venom
510(k) Number K132076
Device Name REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
Applicant
Dsrv, Inc.
780 Park N. Blvd.
Suite 100
Clarkston,  GA  30021
Applicant Contact LAWANDA WASHINGTON
Correspondent
Dsrv, Inc.
780 Park N. Blvd.
Suite 100
Clarkston,  GA  30021
Correspondent Contact LAWANDA WASHINGTON
Regulation Number864.8950
Classification Product Code
GIR  
Date Received07/03/2013
Decision Date 01/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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