510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K143348Substantially Equivalent

BC-3600 Auto Hematology Analyzer

Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143348 is the FDA 510(k) clearance record for BC-3600 Auto Hematology Analyzer, a class II device, cleared for Mindray Bio-Medical Electronics Co., Ltd. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 2 510(k) clearances for Mindray Bio-Medical Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K143348.

Clearance record

Decision date
Received
(273 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Mindray Bio-Medical Electronics Co., Ltd. Mindray Bldg., Keji 12th Rd. S., Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260