Cleared Traditional

K903874 - FIBRINOTEST(TM) - FIBRINOGEN ASSAY

K903874 is an FDA 510(k) clearance for FIBRINOTEST(TM) - FIBRINOGEN ASSAY, manufactured by Haemachem, Inc.. The device is a Class 2 Hematology device with product code GIS cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K903874 · Haemachem, Inc. · Hematology device
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Feb 1991
Decision
176d
Days
Class 2
Risk

K903874 is an FDA 510(k) clearance for the FIBRINOTEST(TM) - FIBRINOGEN ASSAY. Classified as Test, Fibrinogen (product code GIS), Class II - Special Controls.

Submitted by Haemachem, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 14, 1991 after a review of 176 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Haemachem, Inc. devices

FDA 510(k) Submission Details - K903874

510(k) Number K903874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1990
Decision Date February 14, 1991
Days to Decision 176 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 113d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIS Device Classification - Class 2, Special Controls

Product Code GIS Test, Fibrinogen
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 - GIS Test, Fibrinogen

All 10
Devices cleared under the same product code (GIS) and FDA review panel - the closest regulatory comparables to K903874.
BIOMERIEUX HEMOLAB FIBRINOMAT
K925494 · Biomerieux Vitek, Inc. · May 1993
IL TEST PT FIBRINOGEN HS
K923921 · Instrumentation Laboratory CO · Oct 1992
FIBRINOGEN DETERMINATION KIT
K913061 · Sigma Diagnostics, Inc. · Oct 1991
FIBRINOGENTEST-O
K881685 · Diatech, Inc. · Aug 1988
KINETIC FIBRINOGEN ASSAY
K881150 · Bio/Data Corp. · Mar 1988
ASSAY KIT, THROMBO-SCREEN
K781880 · Pacific Hemostasis · Dec 1978