Cleared Traditional

FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3

K946193 · More Diagnostics · Hematology
Aug 1995
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K946193 is an FDA 510(k) clearance for the FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3, a Plasma, Fibrinogen Control (Class II — Special Controls, product code GIL), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on August 24, 1995, 247 days after receiving the submission on December 20, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K946193 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1994
Decision Date August 24, 1995
Days to Decision 247 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GIL — Plasma, Fibrinogen Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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