Cleared Special

REAGENT, RUSSEL VIPER VENOM - LA CONFIRM

K132076 · Dsrv, Inc. · Hematology

Jan 2014

Decision

191d

Days

Class 1

Risk

About This 510(k) Submission

K132076 is an FDA 510(k) clearance for the REAGENT, RUSSEL VIPER VENOM - LA CONFIRM, 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, 191 days after receiving the submission on July 3, 2013. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8950.

Submission Details

510(k) Number	K132076 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2013
Decision Date	January 10, 2014
Days to Decision	191 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Statement