Cleared Traditional

K803218 - CELL DYN 800 HEMATOLOGY ANALYZER

K803218 is the FDA 510(k) clearance for CELL DYN 800 HEMATOLOGY ANALYZER by Abbott Diagnostics. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K803218 · Abbott Diagnostics · Hematology device
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Jun 1981
Decision
173d
Days
Class 2
Risk

K803218 is an FDA 510(k) clearance for the CELL DYN 800 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 June 9, 1981 after a review of 173 days - an extended review 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: 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 Abbott Diagnostics devices

Submission Details

510(k) Number K803218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1980
Decision Date June 09, 1981
Days to Decision 173 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 113d · This submission: 173d
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 K803218.
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
PLATELET COUNTING KIT
K802636 · Streck Laboratories, Inc. · Dec 1980
LEUKOCYTE VOL. ANALYSIS APPARATUS
K802208 · Coulter Electronics, Inc. · Sep 1980