Kyotest UK Urine Test Reagent Strip

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841715 ↗

FDA Product Code

JIN

Device Class

Class I

Regulation

21 CFR Part 862.1435

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Urine Analyzer System

  Class I

  FDA 510(k) K840996 Active Cleared 1 May 1984

• Kyotest 5V

  Class I

  FDA 510(k) K840827 Active Cleared 14 May 1984

• Additional Kyotest Urine Test Reagent Strips

  Class II

  FDA 510(k) K861733 Active Cleared 25 Jul 1986

• Kyotest Ugk

  Class II

  FDA 510(k) K840829 Active Cleared 19 Apr 1984

• Kyotest Ug Urine Test Reagent Strip

  Class II

  FDA 510(k) K841713 Active Cleared 31 May 1984

• Kyotest 8V

  Class I

  FDA 510(k) K840828 Active Cleared 14 May 1984

See all devices from Kyoto Diagnostics, Inc. →