# K993941: UBAS

- Pathway: 510(k) (Traditional)
- Applicant: Marukin Diagnostics
- Decided: Mar 2, 2000 after 104 days
- Product code: KWX (Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids)
- Device class: 2
- Regulation: 21 CFR 862.1187
- 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 Marukin Diagnostic's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary totat bile acid sulfate (UBAS) in children and adults.

Source page: https://510kreport.com/device/K993941
Methodology: https://510kreport.com/methodology