Cleared Traditional

K935212 - IL TEST HEPARIN (XA), PN 84699-15

K935212 is an FDA 510(k) clearance for IL TEST HEPARIN (XA), manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K935212 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
101d
Days
Class 2
Risk

K935212 is an FDA 510(k) clearance for the IL TEST HEPARIN (XA), PN 84699-15. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 101 days - within the typical 510(k) review window.

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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K935212

510(k) Number K935212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1993
Decision Date February 07, 1994
Days to Decision 101 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
12d faster than avg
Panel avg: 113d · This submission: 101d
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 30
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K935212.
THE STACHROM HEPARIN ASSAY KIT
K925433 · American Bioproducts Co. · May 1995
STACLOT HEPARIN TEST KIT
K943517 · American Bioproducts Co. · May 1995
HEMOLAB HEPARICHROM ASSAY
K934274 · Biomerieux Vitek, Inc. · May 1994
BERICHROM HEPARIN
K925200 · Behring Diagnostics, Inc. · Jun 1993
HITT BY HEMOCHRON(R)
K910181 · International Technidyne Corp. · May 1991
HEPARIN CONTROLS, HIGH AND LOW
K910741 · Sigma Diagnostics, Inc. · Apr 1991