Cleared Traditional

K883753 - COULTER CLONE T1 MONOCLONAL ANTIBODY

K883753 is an FDA 510(k) clearance for COULTER CLONE T1 MONOCLONAL ANTIBODY, 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 154-day FDA review.

K883753 · Coulter Immunology · Hematology device
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Feb 1989
Decision
154d
Days
Class 2
Risk

K883753 is an FDA 510(k) clearance for the COULTER CLONE T1 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 154 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.

FDA 510(k) Submission Details - K883753

510(k) Number K883753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1988
Decision Date February 03, 1989
Days to Decision 154 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 113d · This submission: 154d
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 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K883753.
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · Abbott Diagnostics · Apr 1989
COULTER 5P CONTROL
K885028 · Coulter Electronics, Inc. · Feb 1989
COULTER CLONE T3 MONOCLONAL ANTIBODY
K883710 · Coulter Immunology · Feb 1989
COULTER CLONE B4 MONOCLONAL ANTIBODY
K884020 · Coulter Immunology · Feb 1989
COULTER STKS
K885093 · Coulter Electronics, Inc. · Dec 1988
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI
K884346 · Coulter Immunology · Dec 1988
K883753 · COULTER CLONE T1 MONOCLONAL ANTIBODY
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