Cleared Traditional

K910473 - CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC

K910473 is an FDA 510(k) clearance for CYTO-STAT/COULTER CLONE T11-RD1/B4-FITC, manufactured by Coulter Immunology. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K910473

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.

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 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K910473.
MONOCLONAL ANTIBODY ANTI-CD2
K901187 · Sigma Chemical Co. · Oct 1991
MONOCLONAL ANTIBODY ANTI-CD5
K901188 · Sigma Chemical Co. · Oct 1991
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