Cleared Traditional

K803218 - CELL DYN 800 HEMATOLOGY ANALYZER

K803218 is an FDA 510(k) clearance for CELL DYN 800 HEMATOLOGY ANALYZER, manufactured by Abbott Diagnostics. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K803218

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
Combination Product No
PCCP Authorized No
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.

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 K803218.
HEMATOLOGY ANALYZER
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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