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510(k) K252607

AllTest Urinary Tract Infection Test by Hangzhou AllTest Biotech Co., Ltd. — Product Code JMT

K252607 is an FDA 510(k) premarket notification submitted by Hangzhou AllTest Biotech Co., Ltd. for the device "AllTest Urinary Tract Infection Test". The FDA issued a decision of Substantially Equivalent on October 30, 2025. The device falls under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)), a Class I device regulated under 21 CFR 862.1510. Hangzhou AllTest Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
August 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Device Class
Class I
Regulation Number
862.1510
Review Panel
CH
Submission Type

Other clearances by Hangzhou AllTest Biotech Co., Ltd.

  • K260342 — AllTest Strep A Rapid Test (April 30, 2026)
  • K251053 — Shinetell PlusTM Digital Early Pregnancy Test (July 15, 2025)
  • K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (April 4, 2025)
  • K242576 — AllTest Viral Transport Medium (April 4, 2025)
  • K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (February 27, 2025)
  • K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (September 27, 2024)
  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
  • K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (June 17, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K233417 — AllTest Fentanyl Urine Test Cassette (October 26, 2023)

Other clearances for product code JMT

  • K251800 — Healgen® URS Test Strips (December 23, 2025)
  • K242767 — Safecare Urinary Tract Infection Test (January 10, 2025)
  • K170118 — Scanostics UTI Check Application Test System (September 21, 2017)
  • K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS (February 17, 2011)
  • K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS) (January 3, 2000)
  • K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (September 1, 1999)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • K960888 — CHEK-STIX U.T.I. SELF-TEST (July 5, 1996)
  • K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (July 1, 1996)
  • K875248 — BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS (February 24, 1988)

FDA data resources