Cleared Traditional

STA -CALIBRATOR HBPM/LMWH KIT

K010350 · Diagnostica Stago, Inc. · Hematology
Apr 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K010350 is an FDA 510(k) clearance for the STA -CALIBRATOR 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, 63 days after receiving the submission on February 5, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K010350 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2001
Decision Date April 09, 2001
Days to Decision 63 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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