Cleared Traditional

K883710 - COULTER CLONE T3 MONOCLONAL ANTIBODY

K883710 is the FDA 510(k) clearance for COULTER CLONE T3 MONOCLONAL ANTIBODY by Coulter Immunology. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K883710 · Coulter Immunology · Hematology device
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Feb 1989
Decision
157d
Days
Class 2
Risk

K883710 is an FDA 510(k) clearance for the COULTER CLONE T3 MONOCLONAL ANTIBODY. 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 February 3, 1989 after a review of 157 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 K883710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1988
Decision Date February 03, 1989
Days to Decision 157 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 113d · This submission: 157d
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 K883710.
QBC MALARIA SYSTEM
K891276 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
K893423 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1989
COULTER 5P CONTROL
K885028 · Coulter Electronics, Inc. · Feb 1989
COULTER STKS
K885093 · Coulter Electronics, Inc. · Dec 1988
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER
K880507 · Coulter Electronics, Inc. · Apr 1988
COULTER CLONE T11 MONOCLONAL ANTIBODY
K875047 · Coulter Electronics, Inc. · Mar 1988