Cleared Special

K073367 - HEMOSIL FIBRINOGEN-C

K073367 is an FDA 510(k) clearance for HEMOSIL FIBRINOGEN-C, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code KQJ cleared through the Special 510(k) pathway after a 27-day FDA review.

K073367 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
27d
Days
Class 2
Risk

K073367 is an FDA 510(k) clearance for the HEMOSIL FIBRINOGEN-C. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 27, 2007 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073367

510(k) Number K073367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2007
Decision Date December 27, 2007
Days to Decision 27 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

KQJ Device Classification - Class 2, Special Controls

Product Code KQJ System, Fibrinogen Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KQJ System, Fibrinogen Determination

All 27
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K073367.
HemosIL Fibrinogen-C
K251968 · Instrumentation Laboratory (IL) Co. · Jul 2025
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
MULTIFIBREN U
K934326 · Behring Diagnostics, Inc. · Apr 1994
K073367 · HEMOSIL FIBRINOGEN-C
Download PDF FDA Summary Instrumentation Labor…