Cleared Traditional

K802208 - LEUKOCYTE VOL. ANALYSIS APPARATUS

K802208 is the FDA 510(k) clearance for LEUKOCYTE VOL. ANALYSIS APPARATUS by Coulter Electronics, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K802208 · Coulter Electronics, Inc. · Hematology device
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Sep 1980
Decision
6d
Days
Class 2
Risk

K802208 is an FDA 510(k) clearance for the LEUKOCYTE VOL. ANALYSIS APPARATUS. 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 September 17, 1980 after a review of 6 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 K802208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1980
Decision Date September 17, 1980
Days to Decision 6 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
107d faster than avg
Panel avg: 113d · This submission: 6d
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 K802208.
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
TECHNICON H6000 HEMATOLOGY SYSTEM
K801155 · Technicon Instruments Corp. · Jun 1980
COULTER COUNTER MODEL S PLUS
K792537 · Coulter Electronics, Inc. · Jan 1980
COULTER COUNTER-BLOOD CELL COUNTER
K792668 · Coulter Electronics, Inc. · Jan 1980