Cleared Traditional

K961439 - ABBOTT CELL-DYN 4000 SYSTEM

K961439 is the FDA 510(k) clearance for ABBOTT CELL-DYN 4000 SYSTEM by Abbott Diagnostics. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K961439 · Abbott Diagnostics · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
186d
Days
Class 2
Risk

K961439 is an FDA 510(k) clearance for the ABBOTT CELL-DYN 4000 SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Diagnostics (Santa Clara, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 186 days - an extended review cycle.

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 Abbott Diagnostics devices

Submission Details

510(k) Number K961439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date October 18, 1996
Days to Decision 186 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 113d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K961439.
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K964618 · Coulter Corp. · Dec 1996
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K955715 · Abbott Laboratories · Oct 1996
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K954594 · Bayer Corp. · Aug 1996
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K961278 · Coulter Corp. · Jul 1996