Cleared Abbreviated

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K081930) - FDA 510(k) Clearance

Class II Hematology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K081930 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
165d
Days
Class 2
Risk

K081930 is an FDA 510(k) clearance for the UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on December 19, 2008 after a review of 165 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K081930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date December 19, 2008
Days to Decision 165 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 113d · This submission: 165d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

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