Cleared Traditional

K960427 - ABBOTT CELL-DYN 3500R SYSTEM

K960427 is the FDA 510(k) clearance for ABBOTT CELL-DYN 3500R SYSTEM by Sequoia Turner Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K960427 · Sequoia Turner Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
94d
Days
Class 2
Risk

K960427 is an FDA 510(k) clearance for the ABBOTT CELL-DYN 3500R SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sequoia Turner Corp. (Santa Clara, US). The FDA issued a Cleared decision on May 2, 1996 after a review of 94 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 Sequoia Turner Corp. devices

Submission Details

510(k) Number K960427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date May 02, 1996
Days to Decision 94 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
19d faster than avg
Panel avg: 113d · This submission: 94d
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
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