Cleared Traditional

K925200 - BERICHROM HEPARIN

K925200 is an FDA 510(k) clearance for BERICHROM HEPARIN, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K925200

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.

KFF Device Classification - Class 2, Special Controls

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 32
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