# K020618: Aalto Scientific Mirco Hematocrit Control

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: May 14, 2002 after 78 days
- Product code: GLK (Control, Hematocrit)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K964452 (1997). 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)
- K964452: Hematachek, Richmond Diagnostics, Inc. (1997) Summary page 1.

## Indications for use
The Aalto Scientific Micro Hematocrit Controls are human blood based solutions intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for hematocrit

Source page: https://510kreport.com/device/K020618
Methodology: https://510kreport.com/methodology