Skip to content

Uropaper Eiken Ag

by Tanabe U.S.A., Inc.

510(k) K932365

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932365 Date26 Nov 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JIL
Device Class
Class II
Regulation
21 CFR Part 862.1340
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Uropaper Eiken Ag is a method, enzymatic, glucose (urinary, non-quantitative) device used in clinical chemistry for the detection of glucose in urine specimens. It is classified as a Class II medical device under FDA regulation 862.1340 with product code JIL.

The device received FDA 510(k) clearance as substantially equivalent (K932365) on November 26, 1993, following submission on April 19, 1993. It is manufactured by Tanabe U.S.A., Inc. and is intended for use in clinical laboratory settings for urinary glucose testing without quantitative measurement.

Other devices from Tanabe U.S.A., Inc.

See all devices from Tanabe U.S.A., Inc. →

Questions

AI-generated answers, 1 Oct 2026

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

  • What is Uropaper Eiken Ag used for?

    Uropaper Eiken Ag is used for the detection of glucose in urine specimens. It is a non-quantitative enzymatic method intended for clinical chemistry applications, providing a qualitative result to indicate the presence or absence of glucose in urine without measuring exact concentration levels.

  • How is Uropaper Eiken Ag supplied and used?

    Uropaper Eiken Ag is supplied as test strips or paper-based devices designed for use with urine specimens in clinical laboratory settings. The device is applied to a urine sample, and a color change indicates glucose presence through an enzymatic reaction, requiring no instrumentation for reading.

  • Is Uropaper Eiken Ag sterile or single-use?

    Uropaper Eiken Ag is not described as sterile in the provided data, and it is intended for single-use in diagnostic testing. Each test strip is used once per urine specimen to avoid cross-contamination and ensure reliable results, consistent with standard in vitro diagnostic practices.