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Ubas Manual Method And Ubas Automated Method

by Marukin Shoyu Co., Ltd.

510(k) K980525

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980525 Date15 Apr 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWX
Device Class
Class II
Regulation
21 CFR Part 862.1187
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ubas Manual Method And Ubas Automated Method is a radioimmunoassay device for the determination of urinary total bile acid sulfate. It is classified as a Class II device and is used in clinical chemistry applications. The device is designed to measure conjugated sulfalithocholic acid, bile acids in urine samples. The Ubas Manual Method And Ubas Automated Method is a diagnostic tool used to determine urinary total bile acid sulfate levels.

The Ubas Manual Method And Ubas Automated Method is supplied with a product code of KWX and is regulated under 21 CFR 862.1187. It has been cleared by the FDA under the 510(k) clearance process, with a decision code of SESE. The device is intended for use in the colorimetric determination of urinary total bile acid sulfate in children and adults. The Ubas Manual Method And Ubas Automated Method is listed in the FDA 510(k) database with the clearance number K980525.