Cleared Traditional

K884605 - COULTER CLONE MO2

K884605 is an FDA 510(k) clearance for COULTER CLONE MO2, 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 285-day FDA review.

K884605 · Coulter Immunology · Hematology device
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Aug 1989
Decision
285d
Days
Class 2
Risk

K884605 is an FDA 510(k) clearance for the COULTER CLONE MO2. 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 August 15, 1989 after a review of 285 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 - K884605

510(k) Number K884605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1988
Decision Date August 15, 1989
Days to Decision 285 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
172d slower than avg
Panel avg: 113d · This submission: 285d
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 K884605.
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN
K890349 · Becton Dickinson Immunocytometry Systems · Dec 1989
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
K895917 · Coulter Immunology · Dec 1989
ARGOS
K895127 · Abx, Inc. · Oct 1989
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
DANAM VECTOR-8+
K892205 · Danam Electronics · Jun 1989
K884605 · COULTER CLONE MO2
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