Cleared Traditional

K894179 - COULTER CLONE MY4 MONOCLONAL ANTIBODY

K894179 is the FDA 510(k) clearance for COULTER CLONE MY4 MONOCLONAL ANTIBODY by Coulter Immunology. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K894179 · Coulter Immunology · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
241d
Days
Class 2
Risk

K894179 is an FDA 510(k) clearance for the COULTER CLONE(R) MY4 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 12, 1990 after a review of 241 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 K894179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1989
Decision Date February 12, 1990
Days to Decision 241 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 113d · This submission: 241d
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 K894179.
SIMULTEST IMK PLUS(TM)
K900078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1990
COULTER JT3
K896873 · Coulter Corp. · Mar 1990
TECHNICON H*2(TM) SYSTEM
K900593 · Technicon Instruments Corp. · Mar 1990
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