# K042379: Anemiapro Self-Screener

- Pathway: 510(k) (Traditional)
- Applicant: Biosafe Laboratories, Inc.
- Decided: Dec 15, 2004 after 105 days
- Product code: KHG (Whole Blood Hemoglobin Determination)
- Device class: 2
- Regulation: 21 CFR 864.7500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 3700 Analyzer: named in the summary without a submission number
- (no number) HemoCue B-Hemoglobin Instrument: named in the summary without a submission number

## Most influential descendants
- K221508: AnemoCheck Home (2023), 0 descendants of its own

## Indications for use
The AnemiaProTM Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.

Source page: https://510kreport.com/device/K042379
Methodology: https://510kreport.com/methodology