Cleared Traditional

LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2

K934741 · Clinical Controls, Inc. · Hematology
Sep 1994
Decision
342d
Days
Class 2
Risk

About This 510(k) Submission

K934741 is an FDA 510(k) clearance for the LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2, a Plasma, Fibrinogen Control (Class II — Special Controls, product code GIL), submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on September 8, 1994, 342 days after receiving the submission on October 1, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K934741 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1993
Decision Date September 08, 1994
Days to Decision 342 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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