# K063407: BC-3200 Auto Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jun 11, 2007 after 214 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: 4 generations back to K823355 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990352: Coulter AC T Diff 2 Analyzer, Coulter Corp. (1999) Summary page 2.

## Indications for use
The BC-3200 auto hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter to be used in clinical laboratories for In Vitro Diagnostic purpose. The intended use of BC-3200 Auto Hematology Analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.

Source page: https://510kreport.com/device/K063407
Methodology: https://510kreport.com/methodology