# K020710: Biotest Hemoglobin Measuring System

- Pathway: 510(k) (Abbreviated)
- Applicant: Biotest Medizintechnik GmbH
- Decided: Aug 14, 2002 after 162 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Biotest Hemoglobin Measuring System is used for quantitative determination of hemoglobin in blood.

Source page: https://510kreport.com/device/K020710
Methodology: https://510kreport.com/methodology