Cleared Abbreviated

K030606 - COULTER LH 750 BODY FLUIDS APPLICATION

K030606 is the FDA 510(k) clearance for COULTER LH 750 BODY FLUIDS APPLICATION by Beckman Coulter, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Abbreviated 510(k) pathway after a 55-day FDA review.

K030606 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
55d
Days
Class 2
Risk

K030606 is an FDA 510(k) clearance for the COULTER LH 750 BODY FLUIDS APPLICATION. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on April 21, 2003 after a review of 55 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K030606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2003
Decision Date April 21, 2003
Days to Decision 55 days
Submission Type Abbreviated
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
58d faster than avg
Panel avg: 113d · This submission: 55d
Pathway characteristics
Standards-based clearance path.

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 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K030606.
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
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TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
K030828 · Beckman Coulter, Inc. · May 2003
CELL-DYN 1800 SYSTEM
K030513 · Abbott Laboratories · May 2003
COULTER ACT 5DIFF AUTOLOADER (AL)
K030291 · Beckman Coulter, Inc. · Apr 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
K030408 · Beckman Coulter, Inc. · Mar 2003
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161 · Beckman Coulter, Inc. · Jul 2002