# K943008: Bioscan Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Labs, Inc.
- Decided: Aug 8, 1994 after 45 days
- Product code: JJB (Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1115
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K971976: Diascreen Reagent Strips (1997), 3 descendants of its own
- K083184: Tearlab Osmolarity System (2009), 1 descendant of its own
- K132066: Inflamma Dry (2013), 0 descendants of its own
- K030650: Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions (2003), 0 descendants of its own
- K981555: Diascreen Reagent Strips (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K943008
Methodology: https://510kreport.com/methodology