Cleared Traditional

K093394 - BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093394 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Hematology device

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Apr 2010

Decision

160d

Days

Class 2

Risk

K093394 is an FDA 510(k) clearance for the BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-.... Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on April 8, 2010 after a review of 160 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number	K093394 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 30, 2009
Decision Date	April 08, 2010
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

47d slower than avg

Panel avg: 113d · This submission: 160d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

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.