Cleared Traditional

FIBRINOGEN CONTROL

K915462 · Sigma Diagnostics, Inc. · Hematology
Mar 1992
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K915462 is an FDA 510(k) clearance for the FIBRINOGEN CONTROL, a Plasma, Fibrinogen Control (Class II — Special Controls, product code GIL), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 4, 1992, 91 days after receiving the submission on December 4, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K915462 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1991
Decision Date March 04, 1992
Days to Decision 91 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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