Cleared Traditional

K842346 - COULTER AUTOMATIC SAMPLE HANDLER

K842346 is the FDA 510(k) clearance for COULTER AUTOMATIC SAMPLE HANDLER by Coulter Electronics, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K842346 · Coulter Electronics, Inc. · Hematology device
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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

Submission Details

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.

Device Classification

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 52
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K842346.
COULTER CHANNELYZER 256
K851736 · Coulter Electronics, Inc. · Jul 1985
COULTER COUNTER MODEL M4
K843303 · Coulter Electronics, Inc. · Dec 1984
COULTER COUNTER MODEL ZM
K843164 · Coulter Electronics, Inc. · Nov 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
COULTER COUNTER M2
K834568 · Coulter Electronics, Inc. · Feb 1984
RDW PARAMETER FOR THE TECHNICON H6000
K834026 · Technicon Instruments Corp. · Jan 1984