Cleared Abbreviated

K050421 - MS 4/5 HEMATOLOGY ANALYZER

K050421 is the FDA 510(k) clearance for MS 4/5 HEMATOLOGY ANALYZER by Melet Schloesing Laboratories USA. It is a Class 2 Hematology device (product code GKZ) cleared through the Abbreviated 510(k) pathway after a 194-day FDA review.

K050421 · Melet Schloesing Laboratories USA · Hematology device
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Aug 2005
Decision
194d
Days
Class 2
Risk

K050421 is an FDA 510(k) clearance for the MS 4/5 HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Melet Schloesing Laboratories USA (El Cajon, US). The FDA issued a Cleared decision on August 31, 2005 after a review of 194 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 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 Melet Schloesing Laboratories USA devices

Submission Details

510(k) Number K050421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date August 31, 2005
Days to Decision 194 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 113d · This submission: 194d
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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K050421.
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
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K051215 · Abbott Laboratories · Jul 2005
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K050057 · Beckman Coulter, Inc. · Feb 2005