Cleared Traditional

K761289 - ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)

K761289 is an FDA 510(k) clearance for ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800), manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K761289 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1977
Decision
98d
Days
Class 2
Risk

K761289 is an FDA 510(k) clearance for the ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800). Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 28, 1977 after a review of 98 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K761289

510(k) Number K761289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1976
Decision Date March 28, 1977
Days to Decision 98 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
15d faster than avg
Panel avg: 113d · This submission: 98d
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 99
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K761289.
COUNTER 700 & HC-700 HEMO 0 REF.
K771107 · Hycel, Inc. · Jul 1977
HEMALOG 8/90
K770666 · Technicon Instruments Corp. · May 1977
LATELET DETERMIN. KIT, CAT NO. 2521
K770385 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1977
COUNTER, BLOOD CELL & HEMATOCRIT
K770034 · Mallinckrodt Critical Care · Feb 1977
HA/3 HEMATOLOGY ANALYZER
K760582 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1976
HA/5 HEMATOLOGY ANALYZER
K760581 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1976