KQJ · Class II · 21 CFR 864.7340

FDA Product Code KQJ: System, Fibrinogen Determination

Leading manufacturers include Behring Diagnostics, Inc., Instrumentation Laboratory CO and Bio/Data Corp..

28
Total
28
Cleared
80d
Avg days
1980
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 28d recently vs 82d historically

FDA 510(k) Cleared System, Fibrinogen Determination Devices (Product Code KQJ)

28 devices
1–24 of 28
Cleared Jul 24, 2025
HemosIL Fibrinogen-C
K251968
Instrumentation Laboratory (IL) Co.
Hematology · 28d
Cleared Dec 27, 2007
HEMOSIL FIBRINOGEN-C
K073367
Instrumentation Laboratory CO
Hematology · 27d
Cleared Jun 29, 2005
DADE THROMBIN REAGENT
K050928
Dade Behring, Inc.
Hematology · 76d
Cleared Oct 09, 1997
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858
Sigma Diagnostics, Inc.
Hematology · 142d
Cleared Apr 19, 1994
MULTIFIBREN U
K934326
Behring Diagnostics, Inc.
Hematology · 228d
Cleared Aug 13, 1993
IL TEST FIBRINOGEN-C
K931721
Instrumentation Laboratory CO
Hematology · 128d
Cleared Mar 09, 1993
FIBRINOGEN RID TEST KIT
K922416
The Binding Site, Ltd.
Hematology · 292d
Cleared Mar 01, 1993
MULTIFIBREN
K925988
Behring Diagnostics, Inc.
Hematology · 96d
Cleared Sep 22, 1992
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
K923593
International Technidyne Corp.
Hematology · 64d
Cleared Jun 26, 1992
QBC FIBRINOGEN
K920258
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 157d
Cleared May 16, 1990
SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)
K900939
Incstar Corp.
Hematology · 77d
Cleared Apr 16, 1990
COAG-A-MATE - RA4
K900895
Organon Teknika Corp.
Hematology · 48d
Cleared Nov 09, 1989
FIBRINOGEN ASSAY KIT
K896052
Medical Diagnostic Technologies, Inc.
Hematology · 22d
Cleared Dec 20, 1988
TURBOX FIBRINOGEN
K884179
Unipath , Ltd.
Hematology · 81d
Cleared May 02, 1984
FIBRINOGEN ASSAY KIT
K841020
Helena Laboratories
Hematology · 51d
Cleared Oct 08, 1981
ACA FIBRINOGEN TEST PACK
K812629
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 24d
Cleared Oct 02, 1981
LABCER FIBRINOGEN ASSAY KIT & CALIBR.
K812570
Sherwood Medical Co.
Hematology · 23d
Cleared Sep 24, 1981
LOW FIBRINOGEN CONTROL
K812108
Bio/Data Corp.
Hematology · 59d
Cleared Jul 10, 1981
FIBRINOGEN CONTROL PLASMA
K811069
American Dade
Hematology · 81d
Cleared Feb 26, 1981
ORTHO QUANTITATIVE FIBRINOGEN ASSAY
K810058
Ortho Diagnostic Systems, Inc.
Hematology · 44d
Cleared Sep 09, 1980
SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA
K801926
Sigma Chemical Co.
Hematology · 28d
Cleared Jan 11, 1980
THROMBOKINETIC FIBRINOGEN ASSAY
K792563
Bio/Data Corp.
Hematology · 30d

About Product Code KQJ - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code KQJ since 1980, with 28 receiving FDA clearance (average review time: 80 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KQJ Product Code

Recent submissions under KQJ have taken an average of 28 days to reach a decision - down from 82 days historically, suggesting improved FDA processing for this classification.

KQJ devices are reviewed by the Hematology panel. Browse all Hematology devices →