510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K093394Substantially Equivalent

Bc-3200 Auto Hematology Analyzer,m-30D Diluent, M-30R Rinse, M-30Cfl Lyse, M-30E-Z Cleanser, M-30Probe Cleanser, Bc-3D C

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

K093394 is the FDA 510(k) clearance record for BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C, a class II device, cleared for Shenzhen Mindray Bio-Medical Electronics Co., Ltd. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 160 510(k) clearances for Shenzhen Mindray Bio-Medical Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K093394.

Clearance record

Decision date
Received
(160 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 55 Northern Blvd., Suite 200, Great Neck NY
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 November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260