Cleared Traditional

K834024 - HEPARINOMETER

K834024 is an FDA 510(k) clearance for HEPARINOMETER, manufactured by Western Laboratories Corp.. The device is a Class 2 Chemistry device with product code KFF cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K834024 · Western Laboratories Corp. · Chemistry device
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Jun 1984
Decision
202d
Days
Class 2
Risk

K834024 is an FDA 510(k) clearance for the HEPARINOMETER. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Western Laboratories Corp. (Walker, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 202 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7525 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Western Laboratories Corp. devices

FDA 510(k) Submission Details - K834024

510(k) Number K834024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1983
Decision Date June 11, 1984
Days to Decision 202 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 88d · This submission: 202d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KFF Assay, Heparin

All 33
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K834024.
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486 · Warner-Lambert Co. · May 1985
HEPARIN ACA ANALYTICAL TEST PACK
K843201 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984
HEPARIN CALIBRATOR ACA
K843202 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984
DIACROM * HEPARIN
K832373 · Wellcome Diagnostics · Sep 1983
CI-TROL HEPARIN CONTROLS, LOW/HIGH
K812424 · American Dade · Oct 1981
HEPARIN ASSAY
K781479 · Dade, Baxter Travenol Diagnostics, Inc. · Feb 1979