Cleared Traditional

K911793 - COULTERCLONE

K911793 is the FDA 510(k) clearance for COULTERCLONE by Coulter Immunology. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K911793 · Coulter Immunology · Hematology device
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Jul 1991
Decision
78d
Days
Class 2
Risk

K911793 is an FDA 510(k) clearance for the COULTERCLONE. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 78 days - a notably fast clearance 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: 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 Coulter Immunology devices

Submission Details

510(k) Number K911793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1991
Decision Date July 09, 1991
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 113d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K911793.
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K901188 · Sigma Chemical Co. · Oct 1991
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K901189 · Sigma Chemical Co. · Oct 1991
NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL
K913259 · Nova Biomedical Corp. · Oct 1991
COULTER(R) MH010
K911385 · Coulter Electronics, Inc. · Jun 1991
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
K904253 · Ortho Diagnostic Systems, Inc. · May 1991
QBC AUTOREADER
K910834 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991