# K991142: Cell-Dyn 1200 System

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Laboratories
- Decided: Jun 23, 1999 after 79 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K870233 (1987). 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)
- K870233: Cell-Dyn 1600 Multiparameter Auto. Hema. Analyzer, Abbott Diagnostics (1987) Summary page 1.
- (no number) Manual Differential: named in the summary without a submission number

## Recalls of this device
- Nov 30, 2009 · Not classified · Z-1698-2011: The use of the device assemblies has been extended to a 6 month useful life.

## Indications for use
The CELL-DYN® 1200 is a multi-parameter hematology analyzer intended to classify the following formed elements of EDTA anti-coagulated blood: White Blood Cell Parameters: Red Blood Cell Parameters: WBC — White Blood Cell or leukocyte count RBC -- Red Blood Cell or erythrocyte count GRAN —Granulocyte absolute count HCT — Hematocrit %GRAN -- Granulocyte percent MCYV -- Mean Corpuscular Volume LYM - Lymphocyte absolute count RDW -- Red Cell Distribution Width %L — Lymphocyte percent MID — Mid-range absolute count Hemoglobin Parameters: %M — Mid-range percent HGB - Hemoglobin concentration Platelet Parameters: MCH -- Mean Cell Hemoglobin PLT — Platelet Count MCHC - Mean Cell Hemoglobin Concentration MPYV — Mean Platelet Volume *PDW — Platelet Distribution Width *PCT — Plateletcrit * Clinical significance has not been established for these parameters. Therefore, they are not reportable in the US

Source page: https://510kreport.com/device/K991142
Methodology: https://510kreport.com/methodology