Cleared Traditional

K925200 - BERICHROM HEPARIN

K925200 is the FDA 510(k) clearance for BERICHROM HEPARIN by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code KFF) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K925200 · Behring Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
255d
Days
Class 2
Risk

K925200 is an FDA 510(k) clearance for the BERICHROM HEPARIN. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on June 28, 1993 after a review of 255 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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

Submission Details

510(k) Number K925200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date June 28, 1993
Days to Decision 255 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
142d slower than avg
Panel avg: 113d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 28
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K925200.
STACLOT HEPARIN TEST KIT
K943517 · American Bioproducts Co. · May 1995
HEMOLAB HEPARICHROM ASSAY
K934274 · Biomerieux Vitek, Inc. · May 1994
IL TEST HEPARIN (XA), PN 84699-15
K935212 · Instrumentation Laboratory CO · Feb 1994
HITT BY HEMOCHRON(R)
K910181 · International Technidyne Corp. · May 1991
HEPARIN CONTROLS, HIGH AND LOW
K910741 · Sigma Diagnostics, Inc. · Apr 1991
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · Organon Teknika Corp. · Oct 1990