Cleared Traditional

STA-QUALITY HBPM/LMWH KIT

K010324 · Diagnostica Stago, Inc. · Hematology
Apr 2001
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K010324 is an FDA 510(k) clearance for the STA-QUALITY HBPM/LMWH KIT, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on April 9, 2001, 66 days after receiving the submission on February 2, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K010324 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2001
Decision Date April 09, 2001
Days to Decision 66 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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