Cleared Traditional

K874763 - CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER

K874763 is an FDA 510(k) clearance for CELLECT MODEL D, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K874763 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
91d
Days
Class 2
Risk

K874763 is an FDA 510(k) clearance for the CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K874763

510(k) Number K874763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date February 18, 1988
Days to Decision 91 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
22d faster than avg
Panel avg: 113d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 285
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K874763.
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER
K880507 · Coulter Electronics, Inc. · Apr 1988
COULTER CLONE T11 MONOCLONAL ANTIBODY
K875047 · Coulter Electronics, Inc. · Mar 1988
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.
K874838 · Coulter Electronics, Inc. · Feb 1988
QBC BLOOD BANK SYSTEM
K874147 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
QBC SYSTEM HEMOGLOBIN
K874427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER
K873734 · Toa Medical Electronics USA, Inc. · Nov 1987