Cleared Traditional

K943967 - ONYX

K943967 is an FDA 510(k) clearance for ONYX, manufactured by Coulter Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K943967 · Coulter Corp. · Hematology device
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Mar 1995
Decision
203d
Days
Class 2
Risk

K943967 is an FDA 510(k) clearance for the ONYX. 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 March 6, 1995 after a review of 203 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

FDA 510(k) Submission Details - K943967

510(k) Number K943967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date March 06, 1995
Days to Decision 203 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 113d · This submission: 203d
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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K943967.
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
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ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)
K932532 · Ortho Diagnostic Systems, Inc. · Apr 1995
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
K941713 · Ortho Diagnostic Systems, Inc. · Apr 1995
SYSMEX K-4500
K943894 · Sysmex Corp. · Feb 1995
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)
K945692 · Dako Corp. · Jan 1995
MONOCLONAL MOUSE ANTI-HUMAN B-CELL
K943284 · Dako Corp. · Nov 1994