URITEST - NITRITE IN URINE TEST— 510(k) K954685

Substantially Equivalent

Tcpi, Inc.

FDA 510(k) clearance K954685 for URITEST - NITRITE IN URINE TEST, Substantially Equivalent on 1996-07-22. Applicant: Tcpi, Inc.. Device class: 1.

Clearance details

Applicant: Tcpi, Inc.
Product code: Code JMT
Device class: Class 1
Regulation: 21 CFR 862.1510
Advisory panel: Clinical Chemistry
Date received: 1995-10-11
Decision date: 1996-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMT

K251800 — Healgen® URS Test Strips2025-12-23
K252607 — AllTest Urinary Tract Infection Test2025-10-30
K242767 — Safecare Urinary Tract Infection Test2025-01-10
K170118 — Scanostics UTI Check Application Test System2017-09-21
K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS2011-02-17

More clearances from Tcpi, Inc.

K981363 — ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST1998-12-22
K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE1998-10-07
K981197 — ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST1998-06-16
K980776 — ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST1998-04-29
K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)1996-08-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.