IND URINARY TRACT INFECTION (UTI) TEST STRIPS— 510(k) K103037

Name: FDA 510(k) clearance K103037
Creator: U.S. Food and Drug Administration
Published: 2012-04-17

Substantially Equivalent

Ind Diagnostic, Inc.

FDA 510(k) clearance K103037 for IND URINARY TRACT INFECTION (UTI) TEST STRIPS, Substantially Equivalent on 2012-04-17. Applicant: Ind Diagnostic, Inc.. Device class: 1.

Clearance details

Applicant: Ind Diagnostic, Inc.
Product code: Code NGJ
Device class: Class 1
Regulation: 21 CFR 862.1510
Advisory panel: Clinical Chemistry
Date received: 2010-10-14
Decision date: 2012-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, B.C., CA

Download summary PDF View on FDA.gov ↗

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Recalls naming K103037

K-number listed on FDA's recall record

Z-0045-2024 — HealthyWiser UriTest" UTI Test Strips REF 900-UTIClass II·Ongoing·Universal Meditech Inc.·20230522

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103037.

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