Cleared Traditional

K903841 - ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARI...

K903841 is an FDA 510(k) clearance for ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARI..., manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K903841 · Organon Teknika Corp. · Hematology device
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Oct 1990
Decision
62d
Days
Class 2
Risk

K903841 is an FDA 510(k) clearance for the ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on October 22, 1990 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Organon Teknika Corp. devices

FDA 510(k) Submission Details - K903841

510(k) Number K903841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date October 22, 1990
Days to Decision 62 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 113d · This submission: 62d
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 29
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K903841.
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
ORTHOKROME* HEPARIN
K900396 · Ortho Diagnostic Systems, Inc. · Mar 1990
IL TEST 97575-15, HEPARIN ASSAY
K864211 · Instrumentation Laboratory CO · Jan 1987
HEPANORM CALIBRATION PLASMA SET
K854762 · American Bioproducts Co. · Mar 1986