Cleared Traditional

PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2

K935598 · Clinical Controls, Inc. · Hematology
May 1995
Decision
529d
Days
Class 2
Risk

About This 510(k) Submission

K935598 is an FDA 510(k) clearance for the PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 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 May 2, 1995, 529 days after receiving the submission on November 19, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K935598 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1993
Decision Date May 02, 1995
Days to Decision 529 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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