# K012934: Cell-Dyn 3200 System with Absolute and Percent Reticulocyte

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Sep 28, 2001 after 28 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: 2 generations back to K872166 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961439: Abbott Cell-Dyn 4000 System, Abbott Diagnostics (1996) Summary page 1.

## Most influential descendants
- K061667: Cell-Dyn Ruby System (2006), 0 descendants of its own

## Indications for use
The CELL-DYN 3200% System with Absolute and Perceat Reticulocyte is an automated, multiparameter hematology analyzer designed to classify the following formed elements of EDTA-anticoagulated blood: White blood Cell Parameters: WBC — White Blood Cell or Leukocyte Count NEU — Neutrophil Absolute Count %N — Neutrophil Percent LYM — Lymphocyte Absolute Count %L — Lymphocyte Percent MONQ — Monocyte Absolute Count %M — Monocyte Percent EOS - Eosinophil Absolute Count %E -- Eosinophil Percent BASO -- Basophil Absolute Count %B -- Basophil Percent Red Blood Cell Parameters: RBC -- Red Blood Cell or Erythrocyte Count HCT -- Hematocrit MCY -- Mean Cell Volume RDW -- Red Cell Distribution Width Hemoglobin Parameters: HGB - Hemoglobin Concentration MCH -- Mean Cell Hemoglobin MCHC - Mean Cell Hemoglobin Concentration Platelet Parameters: PLT - Platelet Count MPV -- Mean Platelet Volume *PDW -- Platelet Distribution Width *PCT -- Plateletcrit Reticulocyte Parameters: RETIC ABS -- Reticulocyte Absolute RETIC% - Reticulocyte Percent of RBC Count * Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.

Source page: https://510kreport.com/device/K012934
Methodology: https://510kreport.com/methodology