Cleared Special

K052905 - MODIFICATION TO COULTER LH 750 HEMATOLO...

K052905 is the FDA 510(k) clearance for MODIFICATION TO COULTER LH 750 HEMATOLO... by Beckman Coulter, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Special 510(k) pathway after a 35-day FDA review.

K052905 · Beckman Coulter, Inc. · Hematology device
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Nov 2005
Decision
35d
Days
Class 2
Risk

K052905 is an FDA 510(k) clearance for the MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER. 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 November 18, 2005 after a review of 35 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K052905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2005
Decision Date November 18, 2005
Days to Decision 35 days
Submission Type Special
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
78d faster than avg
Panel avg: 113d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 K052905.
COULTER LH 780 HEMATOLOGY ANALYZER
K061616 · Beckman Coulter, Inc. · Oct 2006
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
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CELL-DYN RUBY SYSTEM
K061667 · Abbott Laboratories · Jul 2006
ITAG MHC TETRAMER CMV ASSAY
K051122 · Beckman Coulter, Inc. · Aug 2005
CELL-DYN SAPPHIRE SYSTEM
K051215 · Abbott Laboratories · Jul 2005
COULTER LH 750 HEMATOLOGY ANALYZER
K050057 · Beckman Coulter, Inc. · Feb 2005