# K981568: Mascot MD Hematology Analyzer, Model MD 800

- Pathway: 510(k) (Traditional)
- Applicant: Cdc Technologies, Inc.
- Decided: Aug 21, 1998 after 112 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: 1 generation back to K885093 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885093: Coulter STKS, Coulter Electronics, Inc. (1988) Summary page 1.

## Most influential descendants
- K983562: Mascot MD Hematology Analyzer/ Model MD 700 (1998), 0 descendants of its own

## Indications for use
The MD 800 is a multi-parameter, automated hematology analyzer used to perform in vitro diagnosis of peripheral human blood in clinical laboratories. The MD 800 reports on the following parameters: White Blood Cells (Leukocytes) WBC Red Blood Cells (Erythrocytes) RBC Hemoglobin Concentration Hgb Hematocrit (relative volume of erythrocytes) Het Mean Corpuscular (erythrocyte) Volume MCV Mean Corpuscular (erythrocyte) Hemoglobin MCH Mean Corpuscular (erythrocyte) Hemogilobin Concentration MCHC Red Blood Cell {(erythrocyte volume) Distribution Width RDW Platelet or Thrombocyte Count Pit Mean Platelet (thrombocyte) Volume MPV Lymphocyte (number) LY# Lymphocyte (percent of WBC) LY% Monocyte (number) MO# Monocyte (percent of WBC) MO% Neutrophil (number) NE# Neutrophil (percent of WBC) NE% Eosinophil (number) EO# Eosinophil (percent of WBC) EO%

Source page: https://510kreport.com/device/K981568
Methodology: https://510kreport.com/methodology