# K143348: BC-3600 Auto Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Aug 21, 2015 after 273 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K823355 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 5.

## Indications for use
The BC-3600 auto hematology analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The BC-3600 auto hematology analyzer provide complete blood count (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV) and leukocyte 3-Part differential (Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran%) for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture or fingerstick. The purpose of the BC-3600 Auto Hematology Analyzer is to identify the normal human patient, with normal system-generated parameters, from patients whose results require additional studies.

Source page: https://510kreport.com/device/K143348
Methodology: https://510kreport.com/methodology