Cleared Traditional

K842346 - COULTER AUTOMATIC SAMPLE HANDLER

K842346 is an FDA 510(k) clearance for COULTER AUTOMATIC SAMPLE HANDLER, 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 43-day FDA review.

K842346 · Coulter Electronics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
43d
Days
Class 2
Risk

K842346 is an FDA 510(k) clearance for the COULTER AUTOMATIC SAMPLE HANDLER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 43 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K842346

510(k) Number K842346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1984
Decision Date July 27, 1984
Days to Decision 43 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
70d faster than avg
Panel avg: 113d · This submission: 43d
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 K842346.
COULTER COUNTER MODEL ZM
K843164 · Coulter Electronics, Inc. · Nov 1984
BLOOD DILUTION VIAL
K844042 · American Scientific Products · Oct 1984
PICOSCAL BLOOD CELL COUNTER PS-4
K842140 · Diagnostic Technology, Inc. · Aug 1984
QUICK-COUNT PLUS 2
K841504 · Seragen Diagnostics, Inc. · Jun 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
CELL-DYN 100 WHOLE BLOOD PLATELET
K840170 · Abbott Diagnostics · Mar 1984