Cleared Traditional

K143348 - BC-3600 Auto Hematology Analyzer

K143348 is the FDA 510(k) clearance for BC-3600 Auto Hematology Analyzer by Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K143348 · Mindray Bio-Medical Electronics Co., Ltd. · Hematology device
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Aug 2015
Decision
273d
Days
Class 2
Risk

K143348 is an FDA 510(k) clearance for the BC-3600 Auto Hematology Analyzer. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 21, 2015 after a review of 273 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 Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K143348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2014
Decision Date August 21, 2015
Days to Decision 273 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
160d slower than avg
Panel avg: 113d · This submission: 273d
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.

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 K143348.
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