# K983562: Mascot MD Hematology Analyzer/ Model MD 700

- Pathway: 510(k) (Special)
- Applicant: Cdc Technologies, Inc.
- Decided: Nov 3, 1998 after 21 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 K885093 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981568: Mascot MD Hematology Analyzer, Model MD 800, Cdc Technologies, Inc. (1998) Summary page 1.

## Indications for use
The MD 700 is a multi-parameter, automated hematology analyzer used to perform in vitro analysis of human peripheral blood in clinical laboratories. The MD 700 reports on the following parameters: White Blood Cells (Leukocytes) wBC Red Blood Cells (Erythrocytes) RBC Hemoglobin Concentration Hgb Hematocrit (relative volume of erythrocytes) Hct Mean Corpuscular (erythrocyte) Volume MCV Mean Corpuscular (erythrocyte) Hemoglobin MCH Mean Corpuscular (erythrocyte) Hemoglobin Concentration MCHC Red Blood Cell (erythrocyte volume) Distribution Width RDW Platelet or Thrombocyte Count PIt Granulocyte (number) GR# Granulocyte (percent of WBC) GR% Lymphocyte (number) LY# Lymphocyte (percent of WBC) LY% Monocyte (number) MO# Monacyte (percent of WBC) MO%

Source page: https://510kreport.com/device/K983562
Methodology: https://510kreport.com/methodology