Cleared Traditional

K955715 - CELL DYN 3500 MULTI-PARAMETER AUTOMATED...

K955715 is an FDA 510(k) clearance for CELL DYN 3500 MULTI-PARAMETER AUTOMATED..., manufactured by Abbott Laboratories. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K955715 · Abbott Laboratories · Hematology device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
313d
Days
Class 2
Risk

K955715 is an FDA 510(k) clearance for the CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Laboratories devices

FDA 510(k) Submission Details - K955715

510(k) Number K955715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1995
Decision Date October 08, 1996
Days to Decision 313 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 113d · This submission: 313d
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 226
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K955715.
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ABBOTT CELL-DYN 4000 SYSTEM
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K954594 · Bayer Corp. · Aug 1996
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K961278 · Coulter Corp. · Jul 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
K961701 · Dako Corp. · Jul 1996