Cleared Traditional

K903665 - CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY

K903665 is an FDA 510(k) clearance for CELL-DYN 1400 MULTI-PARAMETER AUTOMATED..., manufactured by Unipath , Ltd.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K903665 · Unipath , Ltd. · Hematology device
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Optimized for regulatory review, auditing and printing
Oct 1990
Decision
50d
Days
Class 2
Risk

K903665 is an FDA 510(k) clearance for the CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Unipath , Ltd. (Mountain View, US). The FDA issued a Cleared decision on October 4, 1990 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K903665

510(k) Number K903665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1990
Decision Date October 04, 1990
Days to Decision 50 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
63d faster than avg
Panel avg: 113d · This submission: 50d
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 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K903665.
DANAM DATACELL-18
K910283 · Danam Electronics · Apr 1991
ANTI-HUMAN LEU-2A (CD8) PE
K904390 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE
K904209 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
ANTI-HUMAN LEU-3A (CD4) FITC
K900802 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1990
EXACT ONE(TM) HEMATOLOGY ANALYZER
K900276 · Exact Science, Inc. · Apr 1990
RDW AND MPV INDICES ON HEMAT 12
K900684 · Texas Intl. Laboratories, Inc. · Apr 1990
K903665 · CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY
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