Cleared Traditional

K832643 - CELL-DYN 900 HEMATOLOGY ANALYZER

K832643 is the FDA 510(k) clearance for CELL-DYN 900 HEMATOLOGY ANALYZER by Abbott Diagnostics. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K832643 · Abbott Diagnostics · Hematology device
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Sep 1983
Decision
53d
Days
Class 2
Risk

K832643 is an FDA 510(k) clearance for the CELL-DYN 900 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 September 26, 1983 after a review of 53 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 Abbott Diagnostics devices

Submission Details

510(k) Number K832643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date September 26, 1983
Days to Decision 53 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 faster than avg
Panel avg: 113d · This submission: 53d
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 K832643.
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
COULTER COUNTER M2
K834568 · Coulter Electronics, Inc. · Feb 1984
RDW PARAMETER FOR THE TECHNICON H6000
K834026 · Technicon Instruments Corp. · Jan 1984
TECHNICON H6000 SYSTEM
K832627 · Technicon Instruments Corp. · Sep 1983
FACS ANALYZER
K832420 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
SYSMEX CC-170
K830507 · Toa Medical Electronics USA, Inc. · May 1983