Cleared Traditional

K963263 - TETRAONE SYSTEM FOR EPICS XL FLOW CYTOM...

K963263 is the FDA 510(k) clearance for TETRAONE SYSTEM FOR EPICS XL FLOW CYTOM... by Coulter Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K963263 · Coulter Corp. · Hematology device
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Jan 1997
Decision
155d
Days
Class 2
Risk

K963263 is an FDA 510(k) clearance for the TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROM.... Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 155 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 Corp. devices

Submission Details

510(k) Number K963263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1996
Decision Date January 22, 1997
Days to Decision 155 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
42d slower than avg
Panel avg: 113d · This submission: 155d
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 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K963263.
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COULTER AC.T SERIES ANALYZER
K964988 · Coulter Corp. · Mar 1997
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
K964754 · Ortho Diagnostic Systems, Inc. · Jan 1997
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL
K962305 · Coulter Corp. · Jan 1997
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL
K962768 · Coulter Corp. · Jan 1997