Cleared Traditional

K925988 - MULTIFIBREN

K925988 is an FDA 510(k) clearance for MULTIFIBREN, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with product code KQJ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K925988 · Behring Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
96d
Days
Class 2
Risk

K925988 is an FDA 510(k) clearance for the MULTIFIBREN. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on March 1, 1993 after a review of 96 days - within the typical 510(k) review window.

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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K925988

510(k) Number K925988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date March 01, 1993
Days to Decision 96 days
Submission Type Traditional
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
17d faster than avg
Panel avg: 113d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K925988.
MULTIFIBREN U
K934326 · Behring Diagnostics, Inc. · Apr 1994
IL TEST FIBRINOGEN-C
K931721 · Instrumentation Laboratory CO · Aug 1993
FIBRINOGEN RID TEST KIT
K922416 · The Binding Site, Ltd. · Mar 1993
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
K923593 · International Technidyne Corp. · Sep 1992
QBC FIBRINOGEN
K920258 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1992
SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)
K900939 · Incstar Corp. · May 1990