Healgen® Accurate Oral Fluid Drug Test— 510(k) K253705

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K253705 for Healgen® Accurate Oral Fluid Drug Test, Substantially Equivalent on 2026-03-16. Applicant: Healgen Scientific,, LLC.

Clearance details

Applicant
Healgen Scientific,, LLC
Product code
Code DJC
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Houston, TX, US
Download summary PDFView on FDA.gov ↗

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