Cleared Traditional

K843164 - COULTER COUNTER MODEL ZM

K843164 is an FDA 510(k) clearance for COULTER COUNTER MODEL ZM, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K843164 · Coulter Electronics, Inc. · Hematology device
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Nov 1984
Decision
92d
Days
Class 2
Risk

K843164 is an FDA 510(k) clearance for the COULTER COUNTER MODEL ZM. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on November 13, 1984 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Electronics, Inc. devices

FDA 510(k) Submission Details - K843164

510(k) Number K843164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date November 13, 1984
Days to Decision 92 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
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 97
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K843164.
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
K850171 · Toa Medical Electronics USA, Inc. · May 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · Abbott Diagnostics · Mar 1985
COULTER COUNTER MODEL M4
K843303 · Coulter Electronics, Inc. · Dec 1984
BLOOD DILUTION VIAL
K844042 · American Scientific Products · Oct 1984
PICOSCAL BLOOD CELL COUNTER PS-4
K842140 · Diagnostic Technology, Inc. · Aug 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346 · Coulter Electronics, Inc. · Jul 1984