Cleared Special

REAGENT, RUSSEL VIPER VENOM - LA SCREEN

K132130 · Dsrv, Inc. · Hematology

Jan 2014

Decision

184d

Days

Class 1

Risk

About This 510(k) Submission

K132130 is an FDA 510(k) clearance for the REAGENT, RUSSEL VIPER VENOM - LA SCREEN, a Reagent, Russel Viper Venom (Class I — General Controls, product code GIR), submitted by Dsrv, Inc. (Clarkston, US). The FDA issued a Cleared decision on January 10, 2014, 184 days after receiving the submission on July 10, 2013. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8950.

Submission Details

510(k) Number	K132130 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2013
Decision Date	January 10, 2014
Days to Decision	184 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Statement