Cleared Traditional

LYPHOCHEK HEMOSTASIS CONTROL

K040275 · Bio-Rad · Hematology
Feb 2004
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K040275 is an FDA 510(k) clearance for the LYPHOCHEK HEMOSTASIS CONTROL, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Bio-Rad (Ivrvine, US). The FDA issued a Cleared decision on February 27, 2004, 22 days after receiving the submission on February 5, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K040275 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2004
Decision Date February 27, 2004
Days to Decision 22 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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