Cleared Traditional

K993356 - COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES

K993356 is an FDA 510(k) clearance for COULTER HEMATOLOGY ANALYZERS WITH IRF &..., manufactured by Coulter Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K993356 · Coulter Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
197d
Days
Class 2
Risk

K993356 is an FDA 510(k) clearance for the COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on April 20, 2000 after a review of 197 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 Coulter Corp. devices

FDA 510(k) Submission Details - K993356

510(k) Number K993356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1999
Decision Date April 20, 2000
Days to Decision 197 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
84d slower than avg
Panel avg: 113d · This submission: 197d
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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K993356.
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
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ADVIA 120 HEMATOLOGY
K003796 · Bayer Corp. · Feb 2001
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K992875 · Sysmex Corp. · Nov 1999
ABX PENTRA 60 HEMATOLOGY ANALYZER
K992511 · Abx Diagnostics · Oct 1999
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · Abbott Laboratories · Sep 1999