Cleared Traditional

K943515 - ROTACHROM HEPARIN TEST KIT

K943515 is the FDA 510(k) clearance for ROTACHROM HEPARIN TEST KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code KFF) cleared through the Traditional 510(k) pathway after a 406-day FDA review.

K943515 · American Bioproducts Co. · Hematology device
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Optimized for regulatory review, auditing and printing
Aug 1995
Decision
406d
Days
Class 2
Risk

K943515 is an FDA 510(k) clearance for the ROTACHROM HEPARIN TEST KIT. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on August 31, 1995 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all American Bioproducts Co. devices

Submission Details

510(k) Number K943515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1994
Decision Date August 31, 1995
Days to Decision 406 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
293d slower than avg
Panel avg: 113d · This submission: 406d
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 K943515.
THE HEPANORM HBPM/LMWH KIT
K943514 · American Bioproducts Co. · Sep 1995
HBPM/LMWH CONTROL KIT
K943519 · American Bioproducts Co. · Sep 1995
HEPARIN CONTROL KIT
K943520 · American Bioproducts Co. · Sep 1995
ROTACHROM HBPM/LMWH TEST KIT
K943516 · American Bioproducts Co. · Aug 1995
THE STACHROM HEPARIN ASSAY KIT
K925433 · American Bioproducts Co. · May 1995
STACLOT HEPARIN TEST KIT
K943517 · American Bioproducts Co. · May 1995