Healgen URS Test Strips— 510(k) K231045

Name: FDA 510(k) clearance K231045
Creator: U.S. Food and Drug Administration
Published: 2023-06-16

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K231045 for Healgen URS Test Strips, Substantially Equivalent on 2023-06-16. Applicant: Healgen Scientific,, LLC. Device class: 1.

Clearance details

Applicant: Healgen Scientific,, LLC
Product code: Code LJX
Device class: Class 1
Regulation: 21 CFR 864.7675
Advisory panel: Hematology
Date received: 2023-04-12
Decision date: 2023-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellaire, TX, US

Download summary PDF View on FDA.gov ↗

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