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YD STRIP GP U20

by Yd Pharmaceutical Corp.

510(k) K834386

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 NumberK834386 Date14 May 1984ClearedStatusActive

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  • Withdrawn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, 27 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 YD STRIP GP U20 is a Method, Enzymatic, Glucose (Urinary, Non-Quantitative) device used in clinical chemistry for the detection of glucose in urine. It is classified as a Class II medical device under regulation number 862.1340.

The device received FDA 510(k) clearance (K834386) on May 14, 1984, and is substantially equivalent to a predicate device. It is manufactured by Yd Pharmaceutical Corp. and is identified by product code JIL.

Other devices from Yd Pharmaceutical Corp.

Questions

AI-generated answers, 27 Sep 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 the YD STRIP GP U20 used for?

    The YD STRIP GP U20 is used for the detection of glucose in urine as a non-quantitative enzymatic method in clinical chemistry settings, providing a qualitative indication of urinary glucose levels.

  • How is the YD STRIP GP U20 supplied and is it single-use?

    The YD STRIP GP U20 is supplied as a test strip intended for single-use application in urine glucose testing; each strip is designed for one-time use to ensure accurate and uncontaminated results.

  • What regulatory clearance does the YD STRIP GP U20 have?

    The YD STRIP GP U20 received FDA 510(k) clearance under K834386 on May 14, 1984, and is classified as a Class II medical device under regulation 862.1340 for clinical chemistry glucose testing.