Cleared Traditional

K823344 - HEMATOLOGY ANALYZER

K823344 is the FDA 510(k) clearance for HEMATOLOGY ANALYZER by Abbott Diagnostics. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K823344 · Abbott Diagnostics · Hematology device
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Dec 1982
Decision
50d
Days
Class 2
Risk

K823344 is an FDA 510(k) clearance for the HEMATOLOGY ANALYZER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 50 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 Abbott Diagnostics devices

Submission Details

510(k) Number K823344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1982
Decision Date December 28, 1982
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 113d · This submission: 50d
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 69
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K823344.
SYSMEX CC-180
K830508 · Toa Medical Electronics USA, Inc. · May 1983
QBC CENTRIFUGAL HEMATOLOGY SYS
K830451 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1983
PROFILE 750 BLOOD CELL COUNTER
K823886 · Mallinckrodt Critical Care · Mar 1983
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
K822758 · Toa Medical Electronics USA, Inc. · Oct 1982
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978 · Technicon Instruments Corp. · Aug 1981
SERIES 810 PLATELET ANALYZER
K803128 · J.T. Baker Chemical Co. · Apr 1981