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510(k) K242767

Safecare Urinary Tract Infection Test by Safecare Biotech (Hangzhou) Co., Ltd. — Product Code JMT

K242767 is an FDA 510(k) premarket notification submitted by Safecare Biotech (Hangzhou) Co., Ltd. for the device "Safecare Urinary Tract Infection Test". The FDA issued a decision of Substantially Equivalent on January 10, 2025. The device falls under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)), a Class I device regulated under 21 CFR 862.1510. Safecare Biotech (Hangzhou) Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2025
Date Received
September 13, 2024
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 Safecare Biotech (Hangzhou) Co., Ltd.

  • K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette (April 10, 2024)
  • K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (March 24, 2021)
  • K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (August 13, 2020)
  • K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (May 27, 2020)
  • K191924 — SAFECARE® THC Urine Strip Test (August 16, 2019)
  • K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (November 19, 2018)
  • K181968 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (August 20, 2018)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)

Other clearances for product code JMT

  • K251800 — Healgen® URS Test Strips (December 23, 2025)
  • K252607 — AllTest Urinary Tract Infection Test (October 30, 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