# K905396: Hemastix Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Feb 11, 1991 after 73 days
- Product code: JIO (Blood, Occult, Colorimetric, In Urine)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031947: Bayer Clinitek Status Analyzer (2003), 16 descendants of its own
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (2009), 6 descendants of its own
- K100024: Teco Diagnostics Uti Detection Strips (2011), 4 descendants of its own
- K231045: Healgen URS Test Strips (2023), 3 descendants of its own
- K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (2014), 3 descendants of its own

Source page: https://510kreport.com/device/K905396
Methodology: https://510kreport.com/methodology