REAGENT, RUSSEL VIPER VENOM - LA CONFIRM— 510(k) K132076

Name: FDA 510(k) clearance K132076
Creator: U.S. Food and Drug Administration
Published: 2014-01-10

Substantially Equivalent

Dsrv, Inc.

FDA 510(k) clearance K132076 for REAGENT, RUSSEL VIPER VENOM - LA CONFIRM, Substantially Equivalent on 2014-01-10. Applicant: Dsrv, Inc.. Device class: 1.

Clearance details

Applicant: Dsrv, Inc.
Product code: Code GIR
Device class: Class 1
Regulation: 21 CFR 864.8950
Advisory panel: Hematology
Date received: 2013-07-03
Decision date: 2014-01-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Clarkston, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIR

view all

K132130 — REAGENT, RUSSEL VIPER VENOM - LA SCREEN2014-01-10
K110031 — HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM2011-08-24
K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA2010-06-25
K061805 — STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM2006-12-06
K000527 — ACCUCLOT DRVVT SCREEN, CATALOG NO. A60942000-04-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.