Cleared Traditional

STA - CONTROL LA 1+2

K061803 · Diagnostica Stago, Inc. · Hematology
Jul 2006
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K061803 is an FDA 510(k) clearance for the STA - CONTROL LA 1+2, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on July 28, 2006, 31 days after receiving the submission on June 27, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K061803 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2006
Decision Date July 28, 2006
Days to Decision 31 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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