Cleared Traditional

MULTIFIBREN U

K934326 · Behring Diagnostics, Inc. · Hematology
Apr 1994
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K934326 is an FDA 510(k) clearance for the MULTIFIBREN U, a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on April 19, 1994, 228 days after receiving the submission on September 3, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K934326 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1993
Decision Date April 19, 1994
Days to Decision 228 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KQJ — System, Fibrinogen Determination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

Similar Devices — KQJ System, Fibrinogen Determination

All 27
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
K251968 · Instrumentation Laboratory (IL) Co. · Jul 2025
HEMOSIL FIBRINOGEN-C
K073367 · Instrumentation Laboratory CO · Dec 2007
DADE THROMBIN REAGENT
K050928 · Dade Behring, Inc. · Jun 2005
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · Sigma Diagnostics, Inc. · Oct 1997
FIF TM
K970189 · Panbio, Inc. · May 1997
N-ASSAY TIA FIBRINOGEN TEST KIT
K965113 · Crestat Diagnostics, Inc. · Apr 1997