Product code JMT— Clinical Chemistry
AllTest Urinary Tract Infection Test
- Classification name
- Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Device class
- Class 1
- Regulation
- 21 CFR 862.1510
- Advisory panel
- Clinical Chemistry
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code JMT
FDA has cleared devices under product code JMT between 1984 and 2025, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2025
- 2017
- 2011
- 2000
- 1999
- 1996
- 1988
- 1986
- 1984
Top applicants under product code JMT
Recent clearances under product code JMT
- K251800 — Healgen® URS Test Strips
- K252607 — AllTest Urinary Tract Infection Test
- K242767 — Safecare Urinary Tract Infection Test
- K170118 — Scanostics UTI Check Application Test System
- K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS
- K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS)
- K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
- K954685 — URITEST - NITRITE IN URINE TEST
- K960888 — CHEK-STIX U.T.I. SELF-TEST
- K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
- K875248 — BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS
- K855238 — BIOTEL (TM)/UTI
- K840828 — KYOTEST 8V
Data sourced from openFDA. This site is unofficial and independent of the FDA.