Cleared Traditional

K910473 - CYTO-STAT/COULTER CLONE T11-RD1/B4-FITC

K910473 is the FDA 510(k) clearance for CYTO-STAT/COULTER CLONE T11-RD1/B4-FITC by Coulter Immunology. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K910473 · Coulter Immunology · Hematology device
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Oct 1991
Decision
269d
Days
Class 2
Risk

K910473 is an FDA 510(k) clearance for the CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC. 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 October 31, 1991 after a review of 269 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 Coulter Immunology devices

Submission Details

510(k) Number K910473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1991
Decision Date October 31, 1991
Days to Decision 269 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 113d · This submission: 269d
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 K910473.
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MONOCLONAL ANTIBODY ANTI-CD3
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