# K071562: D3 Hematology Analyzer, Model D3

- Pathway: 510(k) (Traditional)
- Applicant: Drew Scientific, Inc.
- Decided: Dec 11, 2007 after 187 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945678 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945678: Datacell 18MS, Danam Electronics (1995) Summary page 1.

## Recalls of this device
- Apr 21, 2017 · Class II · Z-2656-2017: May result in elevated platelet backgrounds during routine startup/background checks.
- Mar 10, 2016 · Class II · Z-1576-2016: The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.

## Indications for use
The DREW D3 Hematology Analyzer is a fully automated (microprocessor controlled) quantitative hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

Source page: https://510kreport.com/device/K071562
Methodology: https://510kreport.com/methodology