Cleared Traditional

K193124 - Unicel DxH 800 Coulter Cellular Analysi...

K193124 is an FDA 510(k) clearance for Unicel DxH 800 Coulter Cellular Analysi..., manufactured by Beckman Coulter. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K193124 · Beckman Coulter · Hematology device
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Apr 2020
Decision
156d
Days
Class 2
Risk

K193124 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 (Miami, US). The FDA issued a Cleared decision on April 16, 2020 after a review of 156 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 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 Beckman Coulter devices

FDA 510(k) Submission Details - K193124

510(k) Number K193124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2019
Decision Date April 16, 2020
Days to Decision 156 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
43d slower than avg
Panel avg: 113d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

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

All 226
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K193124.
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