# K992444: Modification of: Cell-Dyn 1200 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 24, 1999 after 64 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CELL-DYN 1700 System: named in the summary without a submission number

## Indications for use
The CELL-DYN 1200 System is an automated, multi-parameter hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory, medical clinic and/or Physician’s Office Laboratory (POL) 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 MCH - Mean Cell Hemoglobin Platelet Parameters: MCHC - Mean Cell Hemoglobin Concentration PLT - Platelet Count MPV — 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/K992444
Methodology: https://510kreport.com/methodology