Cleared Traditional

STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM

K061805 · Diagnostica Stago, Inc. · Hematology
Dec 2006
Decision
162d
Days
Class 1
Risk

About This 510(k) Submission

K061805 is an FDA 510(k) clearance for the STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM, a Reagent, Russel Viper Venom (Class I — General Controls, product code GIR), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on December 6, 2006, 162 days after receiving the submission on June 27, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8950.

Submission Details

510(k) Number K061805 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2006
Decision Date December 06, 2006
Days to Decision 162 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIR — Reagent, Russel Viper Venom
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8950

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